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

May 11, 2023 updated by: M. Ammar Ahmad Sohail, University of Faisalabad

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Muhammad Hospital, Samnabad
      • Faisalabad, Punjab, Pakistan, 38000
        • Physio & Pain Care Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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.
Other: Manual Diaphragm Technique
Treatment group will receive Manual Diaphragm Technique in addition to Conventional Physical Therapy. Therapist will make physical contact to the underside of the 7th to 10th rib costal cartilages. During the inspiratory phase, the therapist will use both hands to gently pull the points of contact in the direction of the head. During exhalation, the therapist will maintain resistance. The procedure will be done in two sets of ten deep breaths, separated by a one-minute pause.
Other: Conventional Physical Therapy

Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Subjects will undergo a thermal continuous ultrasound, conventional transcutaneous electrical nerve stimulation and a hot pack.

Stretching activities for the back, iliopsoas, and hamstring muscles, as well as abdominal muscle strengthening exercises, will be included in the workout.
Active Comparator: Group B
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.
Other: Conventional Physical Therapy

Conventional Physical Therapy group comprises electrotherapeutic treatment and exercise plan. Subjects will undergo a thermal continuous ultrasound, conventional transcutaneous electrical nerve stimulation and a hot pack.

Stretching activities for the back, iliopsoas, and hamstring muscles, as well as abdominal muscle strengthening exercises, will be included in the workout.

Other: Sham Diaphragm Manual Technique
The Control group will also receive a sham diaphragm release technique. The therapist and participant will have the same manual contacts, duration, and placement as the treatment group, but the therapist will simply use a light touch with the same anatomical landmarks and will not apply pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numerical Pain Rating Scale (Pain)
Time Frame: 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 from baseline at 2nd week and Change from 2nd week at 4th week.
Change in Universal Goniometer (Lumbar Range of Motion)
Time Frame: 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.
Change from baseline at 2nd week and Change from 2nd week at 4th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oswestry Disability Index (Back Function Disability)
Time Frame: 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 from baseline at 2nd week and Change from 2nd week at 4th week.
Change in Short Form 12 Health Survey (Health Related Quality of Life)
Time Frame: 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.
Change from baseline at 2nd week and Change from 2nd week at 4th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Investigators

  • Principal Investigator: Dr. Mariam Mehmood, MS-OMPT, University of Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRMAAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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