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

Primary Purpose

Low Back Pain, Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Manual Diaphragm Technique
Conventional Physical Therapy
Sham Diaphragm Manual Technique
Sponsored by
University of Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Manual Therapy, Conventional Physical Therapy

Eligibility Criteria

20 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Muhammad Hospital, Samnabad
  • Physio & Pain Care Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in Numerical Pain Rating Scale (Pain)
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)
Universal Goniometer will be used to measure Lumbar Range of Motion.

Secondary Outcome Measures

Change in Oswestry Disability Index (Back Function Disability)
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)
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.

Full Information

First Posted
March 4, 2022
Last Updated
May 11, 2023
Sponsor
University of Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05299216
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Chronic Low-back Pain
Keywords
Low Back Pain, Manual Therapy, Conventional Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Diaphragm Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Diaphragm Manual Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Numerical Pain Rating Scale (Pain)
Description
Numerical Pain Rating Scale will be used to measure back pain. Score of scale ranges from 0 (no pain) to 10 (worst possible pain).
Time Frame
Change from baseline at 2nd week and Change from 2nd week at 4th week.
Title
Change in Universal Goniometer (Lumbar Range of Motion)
Description
Universal Goniometer will be used to measure Lumbar Range of Motion.
Time Frame
Change from baseline at 2nd week and Change from 2nd week at 4th week.
Secondary Outcome Measure Information:
Title
Change in Oswestry Disability Index (Back Function Disability)
Description
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).
Time Frame
Change from baseline at 2nd week and Change from 2nd week at 4th week.
Title
Change in Short Form 12 Health Survey (Health Related Quality of Life)
Description
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.
Time Frame
Change from baseline at 2nd week and Change from 2nd week at 4th week.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male Gender
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Mariam Mehmood, MS-OMPT
Organizational Affiliation
University of Faisalabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhammad Hospital, Samnabad
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Facility Name
Physio & Pain Care Clinic
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26386894
Citation
Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
Results Reference
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Citation
Ozkaraoglu DK, Tarakci D, Algun ZC. Comparison of two different electrotherapy methods in low back pain treatment. J Back Musculoskelet Rehabil. 2020;33(2):193-199. doi: 10.3233/BMR-181199.
Results Reference
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PubMed Identifier
25202177
Citation
Kachanathu SJ, Alenazi AM, Seif HE, Hafez AR, Alroumim MA. Comparison between Kinesio Taping and a Traditional Physical Therapy Program in Treatment of Nonspecific Low Back Pain. J Phys Ther Sci. 2014 Aug;26(8):1185-8. doi: 10.1589/jpts.26.1185. Epub 2014 Aug 30.
Results Reference
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PubMed Identifier
32000363
Citation
Alsufiany MB, Lohman EB, Daher NS, Gang GR, Shallan AI, Jaber HM. Non-specific chronic low back pain and physical activity: A comparison of postural control and hip muscle isometric strength: A cross-sectional study. Medicine (Baltimore). 2020 Jan;99(5):e18544. doi: 10.1097/MD.0000000000018544.
Results Reference
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PubMed Identifier
23380824
Citation
Joshi VD, Raiturker PP, Kulkarni AA. Validity and reliability of English and Marathi Oswestry Disability Index (version 2.1a) in Indian population. Spine (Phila Pa 1976). 2013 May 15;38(11):E662-8. doi: 10.1097/BRS.0b013e31828a34c3.
Results Reference
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PubMed Identifier
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Citation
Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.
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PubMed Identifier
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Citation
Ibrahim AA, Akindele MO, Ganiyu SO, Kaka B, Abdullahi BB, Sulaiman SK, Fatoye F. The Hausa 12-item short-form health survey (SF-12): Translation, cross-cultural adaptation and validation in mixed urban and rural Nigerian populations with chronic low back pain. PLoS One. 2020 May 7;15(5):e0232223. doi: 10.1371/journal.pone.0232223. eCollection 2020.
Results Reference
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Citation
Marti-Salvador M, Hidalgo-Moreno L, Domenech-Fernandez J, Lison JF, Arguisuelas MD. Osteopathic Manipulative Treatment Including Specific Diaphragm Techniques Improves Pain and Disability in Chronic Nonspecific Low Back Pain: A Randomized Trial. Arch Phys Med Rehabil. 2018 Sep;99(9):1720-1729. doi: 10.1016/j.apmr.2018.04.022. Epub 2018 May 19.
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Effect of Diaphragm Manual Therapy With Conventional Physical Therapy in Chronic Non-Specific Low Back Pain Patients

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