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

NCT05299216 | Completed

• 1 other identifier: DRMAAS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Chronic Low-back Pain

Keywords

Low Back Pain, Manual Therapy, Conventional Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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 from baseline at 2nd week and Change from 2nd week at 4th week.

• Change in Universal Goniometer (Lumbar Range of Motion)

  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 Outcomes (2)

• Change in Oswestry Disability Index (Back Function Disability)

  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)

  Change from baseline at 2nd week and Change from 2nd week at 4th week.

Study Arms (2)

Group A

EXPERIMENTAL

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; Other: Conventional Physical Therapy

Group B

ACTIVE COMPARATOR

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; Other: Sham Diaphragm Manual Technique

Interventions

Manual Diaphragm Technique OTHER

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.

Group A

Conventional Physical Therapy OTHER

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.

Group A; Group B

Sham Diaphragm Manual Technique OTHER

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.

Group B

Eligibility Criteria

• Age: 20 Years - 55 Years
• Gender Eligibility Details: Male Gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (2)

Muhammad Hospital, Samnabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

Physio & Pain Care Clinic

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 26386894 BACKGROUND

• 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.

  PMID: 31594200 BACKGROUND

• 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.

  PMID: 25202177 BACKGROUND

• 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.

  PMID: 32000363 BACKGROUND

• 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.

  PMID: 23380824 BACKGROUND

• 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.

  PMID: 33781267 BACKGROUND

• 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.

  PMID: 32379769 BACKGROUND

• 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.

  PMID: 29787734 BACKGROUND

• Comachio J, Magalhaes MO, Campos Carvalho E Silva APM, Marques AP. A cross-sectional study of associations between kinesiophobia, pain, disability, and quality of life in patients with chronic low back pain. Adv Rheumatol. 2018 Jun 22;58(1):8. doi: 10.1186/s42358-018-0011-2.

  PMID: 30657061 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Mariam Mehmood, MS-OMPT

  University of Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)