Comparative efficacy of two multimodal treatments on ... - IOS Press

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Journal of Back and Musculoskeletal Rehabilitation 23 (2010) 1–9 DOI 10.3233/BMR-2010-0241 IOS Press

Comparative efficacy of two multimodal treatments on male and female sub-groups with low back pain (part II) Suraj Kumara,∗, Vijai P. Sharmaa, Rakesh Shukla b and Ravi Devc a

Department of Physical Medicine and Rehabilitation, Chatrapati Sahuji Maharaj Medical University, Lucknow, India b Department of Neurology, Chhatrapati Sahuji Maharaj Medical University, Lucknow, India c Department of Neurosurgery, Chhatrapati Sahuji Maharaj Medical University, Lucknow, India

Abstract. Objective: This study determines the efficacy of two such multimodal treatments in the management of lumbar pain syndrome in males and females. Method: Total subjects of 141 male or female were randomized to treat either with conventional treatment or by DMST (dynamic muscular stabilization techniques). After stratification on the basis of gender (51 male and 21 female) were found in DMST group whereas (40 male and 29 female) were found in conventional group. The primary outcome measures were pain severity, physical strength (BPC and APC), functional ability (Walking, Stairs climbing and Stand-ups) and QOL. All patients were assessed at baseline (day 0), 10 days, 20 days, 90 days and at the end treatment or follow up (day 180). Result: In this study the improvement of pain, BPC, APC, Walking, Stair climbing and stand-ups in females and males were 22.5% and 29.0%, 60.9% and 53.7%, 42.0% and 51.9%, 49.8% and 49.3%, 54.2% and 48.7%, 52.3% and 39.7%, higher respectively in DMST as compared to CONV whereas QOL in females of DMST improved by 53.6% more than the females of CONV while males of DMST improved by 57.9% more than the males of CONV. Conclusion: DMST as well as CONV treatments are more effective in males than the females. Study also concluded that subgroup “female” may need more clinical attention during the management of LBP. Keywords: Back pain, physiotherapy, rehabilitation, occupational therapy, subgroups, stabilization, strengthening exercises

1. Introduction Low back pain (LBP) is one of the most common problems suffered worldwide. Low back pain poses large challenge to the healthcare strategies despite improved scientific knowledge and technology, medical insight, and suggested management designs [27]. To manage LBP greater insight has been gained “on what not to do with patients” rather than “what to do for ∗ Address

for correspondence: Suraj Kumar, Department of PMR, CSM Medical University, Lucknow (UP) 2260018, India. Tel.: +91 522 2611055; Fax: +91 522 2329408; E-mail: surajdr2001@ yahoo.com.

them” [4]. The LBP can be extremely disabling, and thus challenging for healthcare system. Cost arises from treatment, investigations, compensation for pain and sufferings and lost work time [2]. Low back pain, like abdominal pain, is a symptom, not a disease. The causes are many but may broadly be classified as spondylogenic or neurogenic and vasogenic, vascular, or psychogenic [22]. Spondylogenic back pain may be defined as pain derived from the spinal column and its associated structures. Neurogenic pain is due to tension, irritation, or compression of a lumbar nerve root or roots and usually cause referral pain symptom down to one or both legs. Viscerogenic back pain is derived from disorders of the kidneys, pelvic viscera’s and retroperitoneal tumors and is

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S. Kumar et al. / Comparative efficacy of two multimodal treatments on male and female sub-groups with low back pain (part II)

not aggravated by activities or relieved by rest. Abdominal aortic aneurysms or peripheral vascular disease also may give rise to backache or symptom resembling sciatica. Pure psychogenic back pain is very rarely seen in clinical practice. Causes of mechanical LBP are generally attributed to acute traumatic event, but these may also include cumulative minor trauma as an etiology. The severity of an acute traumatic event varies widely, from twisting one’s back to being involved in a motor vehicle collision. Mechanical LBP due to cumulative minor trauma tends to occur more commonly in the workplace. The LBP is a multifactorial disorder with many possible causes. Treatment of LBP varies considerably. It includes medication, physical therapy modalities and exercise therapy [25] each having several interventions. Practice guidelines recommend numerous kinds of exercises and manipulative therapy for chronic LBP there are only a few head-to-head comparisons of these interventions [19]. In recent years, multidisciplinary pain programs were tried successfully to treat patients such as physical exercises and psychological interventions [23]. However, in spite of their effectiveness, it still remains to be clarified exactly which features of these programs is really responsible for providing relief to the patient [23]. Interventions such as an application of heat, short wave diathermy or massage etc. alone have insufficient evidence to support their effectiveness, but found to be effective and more cost effective than no intervention. One of the major factors in the etiology and chronicity of low back pain is considered to be the lack of control of lumbar stability. The lumbar multifidus muscle plays a very significant role in maintaining lumbar stability and stiffness. Therapeutic exercises, as part of rehabilitation for patients with LBP, are one of the treatment modalities most commonly used by physiotherapists [21]. In the management of such cases, the dynamic muscular stabilization techniques (DMST) were also found to be effective [17]. Through DMST adequate dynamic control of lumbar spine forces is achieved thus it reduces the repetitive injury to the structures of the spinal segments and related structures. Specific stabilizing exercises with co-contraction of deep abdominal, transversus abdominis (TA) and lumbar multifidus (MF) muscles enhance the spinal segmental support and control [24]. In recent clinical trials, these exercises have been proved to be effective in the management of LBP both in short term and long term [8]. Keeping the present scientific knowledge and recommendation of the research board of CSM Medical

University in mind the study has been undertaken to “DMST” an active approach in comparison to routinely used ultrasound and short wave diathermy along with lumbar strengthening exercises protocol named as “conventional” (CONV). It has been proven earlier as a part of this study that DMST intervention is more effective than the CONV [12,14]. Besides this, the study aimed to determine the sex (male and female) wise efficacy of two treatments. The effect of both the physical therapy approaches was tested in subjects on pain severity, physical strengths, functional ability and quality of life with sub acute and chronic low back pain. The hypothesis of the study to determine the efficacy in males and females those were receiving DMST or CONV treatment.

2. Methods 2.1. Subject A total 141 (male/Female) LBP patients from Department of Physical Medicine and Rehabilitation, CSM Medical University, Lucknow, aged 20–40 years who were diagnosed clinically by a physician with no neurological involvement, nonspecific, sub-acute or chronic low back pain were included for this study. All patients were randomized to treat either with Conventional or DMST. The present study has the approval of the Institutional Review Board and informed consent was obtained from all the participants. 2.2. Approach The subjects were randomized equally in two groups by lottery method. For this, two hundred folded papers of same shape and size were marked either Conventional or DMST were kept in a box and mixed thoroughly before and after withdrawing a paper from the box. Marking on the paper drawn by the patient allocates his mode of treatment. The demographic characteristics such as age, weight, height, waist circumference (WC), hip circumference (HC), BMI (body mass index) and duration of LBP (Duration) of two treatment groups were assessed at baseline before randomization. Similarly, outcome variables such as pain severity, physical strength (BPC and APC), functional ability (Walking, Stairs climbing and Stand-ups) and QOL were also assessed by same tester and same physiotherapist supervising the test procedure at base line (day 0) as well end of the treatment (day 180). Test and retest of two


groups were conducted in the same place at same environment and at the same time of the day. Before experimentation, all subjects were well taught about the measurement variables and their outcomes. The patients were also informed about the experimental risks, if any. 2.3. Procedure After group allocations, respective subjects were treated either with Conventional (CONV) or DMST in a single blind manner i.e. patients were not aware of the treatments groups. Both the treatments were given as individual treatment by the same physiotherapist with the same intensity and capacity on 20 regular days and follow up for 180 days. Follow up was started after 20 days of regular exercises at OPD which was ended after 6 months from the 0 day. During follow up, subjects had an appointment periodically with the investigator at 15 days interval for review of exercises. The duration of each individual treatment session was about 40 minutes per day. The subjects were not allowed to get any other treatment options including the pain killers. The brief description of both the treatments protocols are as follows: 2.3.1. Conventional treatment Consisted of Ultrasound (1 MHz Continuous at intensity 1.2 W per cm square for 5 minutes) Short wave diathermy (Continuous mode of SWD for 15 minutes) and the lumber strengthening exercises (10 repetitions each of prone lying leg elevation, prone lying chest elevation and supine lying bridging). Subjects received 20 sitting in 20 regular days. Ultrasound and SWD equipments of Medichem Electronics were used in the study which has International standard certification. 2.3.2. Dynamic muscular stabilization treatment (DMST) In DMST, muscles with direct attachment to lumbar spinal segment are stabilizes the joints ‘neutral zone’ and prevent excessive deflection. Details of DMST exercise program described elsewhere [14]. 2.4. Outcome variables Pain was the primary outcome measure while physical strength (BPC and APC), functional ability (Walking, Stair climbing, Stand ups) and QOL the secondary. These variables were assessed using VAS (visual analogue scale), Waddle functional evaluation test [28] and

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SF-36 questionnaire respectively. The details of VAS, BPC, APC, Walking, Stair climbing, Stand ups and SF36 outcome variables are summarize as below: Visual analogue scale (VAS) – This is a 10 cm calibrated line with 0 representing no pain and 10 representing worst pain. The subjects were asked to make a mark or point on the scale that best represents his intensity of pain experienced [10]. BPC and APC are well documented in previous publication in the same study [13]. 5 minutes of walking – The distance subject actually covered in 5 minute by walking between the two marks separated 10 meter apart in a nonslipery, quite corridor. Subject was not allowed to use any walking aid but was permitted to use the walls for support or sit down when tired. During the test the subject was given continuous feedback about the time elapsed. One minute stair climbing – The test involved climbing up and down of standard stairs having one handrail and opposite wall within easy reach for one minute. Stair climbing scores of a subject was taken as total steps completed both up and down in one minute example e.g. a patient who climbed up 10 steps and climbed down 18 steps, would score 28. One minute stand ups – The test involved repeated standing up and sitting down from a firm chair having a back rest but no arm rest in 1 minute. The seat height of chair was 45 centimeter. During stand up there was no any support within reach to prevent the patient from using any support. SF–36 quality of life – It is a multipurpose, self administered, short form (SF) health survey with 36 questions which measures generic health status on general population [11]. These questions intend to obtain information on the physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role functioning and mental health. Response choices are numbered from left to right, starting with 1. The maximum scores obtained from 36 questions are 151 represents worst quality of life whereas minimum score 36 represents the best. 2.5. Subgroups The stratification of subjects of two treatment groups was done on the basis of their gender. The proportions of females and males in both the treatment groups were summarized in Table 1 and also shown graphically by Fig. 1. 2.6. Statistical analysis A mixed model two way repeated measures ANOVA, with treatments as a between subjects variable (CONV

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Females 29%

Females 42% Male s 58%

CONV

Males 71%

DMST

Fig. 1. Sex wise distribution of subjects of groups. Table 1 Sex wise distribution of subjects in two groups Sex

Females Males

CONV (N = 69) N % 29 42 40 58

DMST (N = 72) N % 21 29 51 71

vs. DMST) and time as a repeated measures variable (baseline vs. follow-up) was used to analyze the outcome variables and the significance of mean differences between the groups was done by Boneferroni post hoc test. The improvement of each outcome variable in two treatments between sex (Male vs. Female) was done separately by two factor ANOVA followed by Boneferroni post hoc test. The improvement for each outcome variable in two treatment groups was evaluated as the respective average scores over the follow up periods (day 10, day 20, 3 month and 6 month) minus baseline score (day 0). STATISTICA (version 6) and MS EXCEL (MS Office 97–2003) were used for the analysis. Probability (P) value between 0.05 (P < 0.05) & 0.01 was considered statistically significant; P < 0.01 as highly significant and P > 0.05 had no significance (ns). For easy interpretations of the data, the percent mean improvement (% mean change of improvement) of one group over other was also evaluated as M ean1 − M ean2 × 100 M ean2 3. Results The demographic characteristics (Table 2) such as age, weight, height, waist circumference (WC), hip circumference (HC), BMI (body mass index) and Pain duration of LBP (PD) of two treatment groups were assessed at baseline and found to be insignificant.

Table 2 Summary (Mean ± SE) of baseline demographic characteristic in subjects of two groups Characteristics Age (yrs) Weight (kg) Height (cm) WC (cm) HC (cm) BMI (kg/m2) PD (month)

CONV (n = 69) 35.83 ± 0.66 66.77 ± 1.56 161.78 ± 1.12 89.43 ± 1.21 48.83 ± 0.68 25.42 ± 0.45 33.13 ± 4.28

DMST (n = 72) 34.36 ± 0.72 67.67 ± 1.23 164.64 ± 1.04 87.40 ± 1.10 49.07 ± 0.54 24.97 ± 0.40 34.15 ± 4.27

t-value (DF = 139) 1.50ns 0.45ns 1.87ns 1.24ns 0.27ns 0.75ns 0.17ns

ns- P > 0.05. WC – Waist circumference, HC – Hip circumference, BMI – Body mass index, PD – Pain duration.

3.1. Pain The improvement of pain in both females and males (sex) of two groups (treatments) were summarized in Table 3 and also shown graphically by Fig. 2. Analyzing the improvement in pain by two factor (sex and treatments) analysis of variance (ANOVA), ANOVA found the factor treatments the significant (F = 33.35; P < 0.01) while factor sex the insignificant (F = 0.17; P > 0.05). The interaction of both the factors (sex*treatments) was also found to be insignificant (F = 0.31; P > 0.05). Therefore, comparing the mean improvement between the groups for each sex, the improvement of pain in females of DMST was found to be significantly (P < 0.05) different and higher than the CONV. Similarly, the improvement of pain in males of DMST was also found to be significantly (P < 0.01) different and higher than the CONV. In conclusion, the improvement of pain in females and males were 22.5% and 29.0% higher respectively in DMST as compared to CONV. 3.2. Back pressure changes The improvement of BPC in both females and males (sex) of two groups (treatments) over the periods were summarized in Table 4 and also shown graphically by

S. Kumar et al. / Comparative efficacy of two multimodal treatments on male and female sub-groups with low back pain (part II) Table 3 Sex wise improvement (Mean ± SE) of pain severity in subjects of two groups

Females Males

CONV 2.83 ± 0.15 2.89 ± 0.15

Pain DMST 3.65 ± 0.20∗ 4.07 ± 0.16∗∗

Improvement (%) 22.5% 29.0%

_ SE Mean +

Sex

15

**

**

5

Females Males

10

5

*- P < 0.05, **- P < 0.01. 0 CONV

5 *

4

DMST Groups

(a)

Females Males

7.5

** **

3 _ SE Mean +

_ SE Mean +

**

2 1

Females Males

5.0

2.5

0 CONV

DMST Groups

0.0 CONV

*- P 0.05). Therefore, comparing the mean improvement between the groups for each sex, the improvement of BPC in females of DMST was found to be significantly (P < 0.01) different and higher than the CONV. Similarly, the improvement of BPC in males of DMST was also found to be significantly (P < 0.01) different and higher than the CONV. In conclusion, the improvement of BPC in females and males were 60.9% and 53.7% higher respectively in DMST as compared to CONV.

DMST Groups

**- P 0.05). In other words, the differences in means were significant between the groups while insignificant within the groups. Therefore, comparing the mean improvement between the groups for each sex, the improvement of APC in females of DMST was found to be significantly (P < 0.01) different and higher than the CONV. Similarly, the improvement of APC in males of DMST was also found to be significantly (P < 0.01) different and higher than the CONV. In conclusion, the improvement of APC in females and males were 42.0% and 51.9% higher respectively in DMST as compared to CONV. 3.4. Walking

3.3. Abdominal pressure changes The improvement of APC in both females and males (sex) of two groups (treatments) over the periods were summarized in Table 4 and also shown graphically by Fig. 3. Analyzing the improvement in APC by two factor (sex and treatments) analysis of variance (ANOVA), ANOVA found the factor treatments the significant (F = 72.14; P < 0.01) while factor sex the insignificant (F = 0.16; P > 0.05). The interaction of

The improvement of walking in both females and males (sex) of two groups (treatments) over the periods were summarized in Table 5 and also shown graphically by Fig. 4. Analyzing the improvement in walking by two factor (sex and treatments) analysis of variance (ANOVA), ANOVA found the factor treatments the significant (F = 39.91; P < 0.01) while factor sex the insignificant (F = 1.76; P > 0.05). The interaction of both the factors (sex*treatments) was also found to


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Table 4 Sex wise improvement (Mean ± SE) of physical strength in subjects of two groups Sex

Physical strength

Females Males

BPC DMST 12.60 ± 0.79∗∗ 12.43 ± 0.55∗∗

CONV 4.93 ± 0.44 5.75 ± 0.50


CONV 3.57 ± 0.40 3.25 ± 0.26

APC DMST 6.15 ± 0.34∗∗ 6.76 ± 0.33∗∗


**- P < 0.01. Table 5 Sex wise improvement (Mean ± SE) of functional ability in subjects of two groups Sex CONV

Walking DMST

Females 15.42 ± 3.02 30.70 ± 2.85∗∗ Males 17.82 ± 1.81 35.16 ± 2.25∗∗

Functional ability Stairs climbing Stand-ups Improvement CONV DMST Improvement CONV DMST Improvement (%) (%) (%) 49.8% 4.05 ± 0.26 8.85 ± 1.31∗∗ 54.2% 3.85 ± 0.38 8.07 ± 0.70∗∗ 52.3% 49.3% 4.31 ± 0.34 8.40 ± 0.49∗∗ 48.7% 4.28 ± 0.38 7.10 ± 0.38∗∗ 39.7%

**- P < 0.01. 40

** **

F emal es M al es

15

F emal es Mal es

_ SE Mean +

_ SE Mean +

30 20 10 0

**

10

**

5

0

CONV (a)

CONV

DMST G roups

(b) 10.0

_ SE Mean +

** **

7.5

DMST G roups

F emal es M al es

5.0 2.5 0.0 CONV (c)

DMST G roups

**- P 0.05). The interaction of both the factors (sex*treatments) was also found to be insignificant (F = 0.35; P > 0.05). Therefore, comparing the mean improvement between the groups for each sex, the improvement of stairs climbing in females of DMST was found to be significantly (P < 0.01) different and higher than the CONV. Similarly, the improvement of stairs climbing in males of DMST was also found to be significantly (P < 0.01) different and higher than the CONV. In conclusion, the improvement of stairs climbing in females and males were 54.2% and 48.7% higher respectively in DMST as compared to CONV.

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**

Females Males

30 20 10 0

3.6. Stand-ups

CONV

DMST Groups

The improvement of stand-ups in both females and males (sex) of two groups (treatments) over the periods were summarized in Table 5 and also shown graphically by Fig. 4. Analyzing the improvement in stand-ups by two factor (sex and treatments) analysis of variance (ANOVA), ANOVA found the factor treatments the significant (F = 57.78; P < 0.01) while factor sex the insignificant (F = 0.35; P > 0.05). The interaction of both the factors (sex*treatments) was also found to be insignificant. Therefore, comparing the mean improvement between the groups for each sex, the improvement of stand-ups in females of DMST was found to be significantly (P < 0.01) different and higher than the CONV. Similarly, the improvement of stand-ups in males of DMST was also found to be significantly (P < 0.01) different and higher than the CONV. In conclusion, the improvement of stand-ups in females and males were 52.3% and 39.7% higher respectively in DMST as compared to CONV. 3.7. Quality of life The improvement of QOL in both females and males (sex) of two groups (treatments) over the periods were summarized in Table 6 and also shown graphically by Fig. 5 Analyzing the improvement in QOL by two factor (sex and treatments) analysis of variance (ANOVA), ANOVA found the factor treatments the significant (F = 124.45; P < 0.01) while factor sex the insignificant (F = 0.32; P > 0.05). The interaction of both the factors (sex*treatments) was also found to be insignificant. Therefore, comparing the mean improvement between the groups for each sex, the improve-

**- P