Clinical trial NCT05299216: Effect of Diaphragm Manual Therapy With Conventional Physical Therapy in Chronic Non-Specific Low Back Pain Patients
Official title: Effect of Conventional Physical Therapy With or Without Diaphragm Manual Therapy in Patients With Chronic Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Chronic Low-back Pain
Keywords: Low Back Pain, Manual Therapy, Conventional Physical Therapy
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Numerical Pain Rating Scale (Pain)
timeFrame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
measure: Change in Universal Goniometer (Lumbar Range of Motion)
timeFrame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Secondary outcomes:
measure: Change in Oswestry Disability Index (Back Function Disability)
timeFrame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
measure: Change in Short Form 12 Health Survey (Health Related Quality of Life)
timeFrame: Change from baseline at 2nd week and Change from 2nd week at 4th week.
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Muhammad Hospital, Samnabad
state: Punjab
city: Faisalabad
country: Pakistan
facility: Physio & Pain Care Clinic
state: Punjab
Study officials:
affiliation: University of Faisalabad
name: Dr. Mariam Mehmood, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
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