Effect of Diaphragm Manual Therapy With Conventional Physical Therapy in Chronic Non-Specific Low Back Pain Patients

Not Applicable

Completed

• Conditions: Low Back Pain; Chronic Low-back Pain
• Interventions: Other: Manual Diaphragm Technique; Other: Sham Diaphragm Manual Technique; Other: Conventional Physical Therapy

• Registration Number: NCT05299216
• Lead Sponsor: University of Faisalabad

Brief Summary

A randomized single-blind clinical study will be performed. A sample size of 34 patients including only male gender, will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment. Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25.

Detailed Description

Over 80% of people experience Lower back pain in their lives, of which 23% suffer from chronic pain. Physiotherapists use multiple treatment options for treating non-specific chronic low back pain such as joint mobilization, therapeutic exercises, electrotherapeutic modalities and soft tissue release techniques.

The objective of the study is to determine the effect of conventional physical therapy with or without diaphragm manual therapy in patients with chronic non-specific low back pain.

A randomized, single-blind clinical study will be performed. A sample size of 34 patients comprising of only male gender will be taken from various clinical settings of Faisalabad. Non-probability purposive sampling technique will be used. Patients will be randomly allocated into two groups. Treatment Group A will perform Conventional Physical Therapy and Diaphragm Manual Therapy and Group B will perform Conventional Physical Therapy and Sham Diaphragm Manual Therapy. Numerical Pain Rating Scale and lumbar range of motion scores will be assessed at pre-treatment, 2nd-week post-treatment and 4th-week post-treatment. Oswestry Disability Index scores and Short Form 12 Health Survey Questionnaire will be assessed at pre-treatment and 4th-week post-treatment.

Statistical analysis will be performed on Statistical Package for the Social Sciences Version 25. Mean ± Standard Deviation will be used to present Quantitative variables while Qualitative variables will be shown through frequency tables and percentages will be shown in the form of frequency tables and percentages. Summary of group measurements will be represented through Graphs. Normal distribution of data will be analyzed through skewness, kurtosis and Shapiro wilk test. If data is found normally distributed, then parametric tests will be applied, which will include an Independent sample t-test for measuring inter-group changes. Paired Sample t-test/Repeated measure ANOVA for measuring intra-group differences. If data is found non-normally distributed, then non-parametric tests will be applied, which will include Mann-Whitney U-Test for measuring inter-group changes and Wilcoxon Test/Friedman Test for measuring intra-group differences. P-value ≤ 0.05 will be taken as significant.

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-28
• Study Start: 2022-04-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

• Age between 20-55 years.
• Male gender
• Patients diagnosed as having non-specific chronic low back pain from the last 12 weeks minimum.
• Pain rating of at least 3 on Numerical Pain Rating Scale.

Exclusion Criteria

• Previous history of spinal trauma, fracture or surgery.
• Patients with lumbar disc herniation and radicular low back pain.
• Patients having any spinal malignancy, psychological distress, infectious disorder or systemic disorder.
• Patients with tuberculosis of the spine.
• Patients with musculoskeletal injuries of the lower extremities.
• Patients who regularly consume anti-inflammatory or analgesic drugs.
• Previous history of manual treatment in the last month.
• Patients having contraindications for manual therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Sham Diaphragm Manual Technique	Group B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week.
Group A	Manual Diaphragm Technique	Group A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week.
Group A	Conventional Physical Therapy	Group A will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Treatment will be provided for a total of four weeks, thrice a week.
Group B	Conventional Physical Therapy	Group B will receive Conventional Physical Therapy and Sham Diaphragm Technique. Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Treatment will be provided for a total of four weeks, thrice a week.

Primary Outcome Measures

Name	Time	Method
Change in Numerical Pain Rating Scale (Pain)	Change from baseline at 2nd week and Change from 2nd week at 4th week.	Numerical Pain Rating Scale will be used to measure back pain. Score of scale ranges from 0 (no pain) to 10 (worst possible pain).
Change in Universal Goniometer (Lumbar Range of Motion)	Change from baseline at 2nd week and Change from 2nd week at 4th week.	Universal Goniometer will be used to measure Lumbar Range of Motion.

Secondary Outcome Measures

Name	Time	Method
Change in Oswestry Disability Index (Back Function Disability)	Change from baseline at 2nd week and Change from 2nd week at 4th week.	Oswestry Disability Index original English version (United States) and Urdu translated version (Pakistan) to measure back function disability. Score of this scale ranges from 0(no disability) to 50(completely disabled).
Change in Short Form 12 Health Survey (Health Related Quality of Life)	Change from baseline at 2nd week and Change from 2nd week at 4th week.	Short Form 12 Health Survey Questionnaire original English version (United States) and Urdu translated version (Pakistan) will be used to assess health related quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Trial Locations

Locations (2)

Physio & Pain Care Clinic; 🇵🇰 Faisalabad, Punjab, Pakistan

Muhammad Hospital, Samnabad; 🇵🇰 Faisalabad, Punjab, Pakistan