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Effects of Cervicothoracic Mobility Program on Low Back Pain

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cervicothoracic mobility program
Conventional Treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Back pain, Cervical mobilization, Thoracic mobilization

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both genders.
  • Age 18-50 years. NPRS between 3 and 6
  • Subjects diagnosed with chronic back pain with minimum 6 months of chronicity
  • ODI score 21 to 40
  • There should be no radiating pain to legs of participants.

Exclusion Criteria:

  • Patients with Systemic soft tissue disease and bony disease will be excluded from the study.
  • Pregnant women will be excluded from the study.
  • Patients with previous orthopedic and neurosurgical surgery will be excluded from the study.
  • Patients with any Red flags (Ankylosing spondylitis, spondylolisthesis, Slipped discs, spinal tumor, spinal stenosis, cauda equine syndrome, and spine infection) will be excluded.
  • Patients with a positive Faber test for SIJ dysfunction will be excluded

Sites / Locations

  • Physiotherapy department of Syed medical complex Sialkot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

Cervicothoracic mobility program

Conventional Treatment

Outcomes

Primary Outcome Measures

NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain
ODI
The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use tomeasure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint. (Also mention all information which ROM u want to check)

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05347251
Brief Title
Effects of Cervicothoracic Mobility Program on Low Back Pain
Official Title
Effects of Cervicothoracic Mobility Program on Pain, Range of Motion and Function in Patients With Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like hot packs and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like the hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles. The session will be around 40 to 45 min for each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion, and function with NPRS (numeric pain rating scale), goniometer, and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.
Detailed Description
Chronic back pain is usually age-related, but can also result from a prior injury. The most common causes include arthritis of the spine, a sedentary lifestyle, and any injury or disc-related problems. Joint mobilization is a physical therapy technique designed to relieve pain and muscle spasms, release tension and improve flexibility in a joint. The aim of this study is to determine the effects of the cervicothoracic mobility program on pain, range of motion, and function in patients with chronic back pain. The study will be a randomized control trial to determine the effects of the cervicothoracic mobility program on pain, range of motion and function in patients with chronic back pain. The purposive sampling technique will be used. A sample of 44 patients will be taken and divided into two groups each with 22 patients. Group A will be the experimental group and group B will be the control group. The experimental group will receive cervical mobility and thoracic mobility along with conventional physical therapy protocols like a hot pack and exercise therapy protocol. Group B will be the control group and will receive the conventional physical therapy protocol like hot pack and exercise therapy protocol. Exercise therapy includes the strengthening and stretching exercises of both neck and back muscles. The session will be around of 40 to 45 min on each patient with three sessions per week on alternate days. A total of 3-week treatment program will be given to the patients and an assessment of the patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometer and ODI (Oswestry disability index) will be done at the baseline and after the completion of treatment at three weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Back pain, Cervical mobilization, Thoracic mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Cervicothoracic mobility program
Arm Title
Group B
Arm Type
Other
Arm Description
Conventional Treatment
Intervention Type
Other
Intervention Name(s)
Cervicothoracic mobility program
Intervention Description
Participants in this group will receive mobilization at a cervical and thoracic level along with conventional physical therapy protocol like Hot packs and exercise therapy. At the cervical, PA glides (central) and transverse glides will be given for mobilization. At thoracic, PA glides (central) and transverse glides will be given for mobilization. Exercise therapy includes stretching and strengthening both cervical and thoracic muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors, extensors, side benders and rotators) will perform as well. Similarly, at the thoracic level, strengthening and stretching of thoracic muscle will be performed
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
It will be the control group. The participants who will be allocated in this group receive the only conventional physical therapy protocol (Hot pack and exercise therapy). Exercise therapy includes stretching and strengthening of neck and upper back muscles. At the cervical level, neck isometric (flexion, extension, side bending) will be given to patients to enhance strengthening, and neck stretching exercises (flexors, extensors, side benders, and rotators) will perform as well. Similarly at the thoracic level, strengthening and stretching of thoracic muscle will be performed.
Primary Outcome Measure Information:
Title
NPRS
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain
Time Frame
3rd Week
Title
ODI
Description
The Oswestry Disability Index is an extremely important tool that researchers and disability evaluators use tomeasure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Time Frame
3rd Week
Title
Goniometer
Description
A goniometer is an instrument which measures the available range of motion at a joint. (Also mention all information which ROM u want to check)
Time Frame
3rd Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders. Age 18-50 years. NPRS between 3 and 6 Subjects diagnosed with chronic back pain with minimum 6 months of chronicity ODI score 21 to 40 There should be no radiating pain to legs of participants. Exclusion Criteria: Patients with Systemic soft tissue disease and bony disease will be excluded from the study. Pregnant women will be excluded from the study. Patients with previous orthopedic and neurosurgical surgery will be excluded from the study. Patients with any Red flags (Ankylosing spondylitis, spondylolisthesis, Slipped discs, spinal tumor, spinal stenosis, cauda equine syndrome, and spine infection) will be excluded. Patients with a positive Faber test for SIJ dysfunction will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy department of Syed medical complex Sialkot
City
Sialkot
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30257670
Citation
Husky MM, Ferdous Farin F, Compagnone P, Fermanian C, Kovess-Masfety V. Chronic back pain and its association with quality of life in a large French population survey. Health Qual Life Outcomes. 2018 Sep 26;16(1):195. doi: 10.1186/s12955-018-1018-4.
Results Reference
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PubMed Identifier
28874980
Citation
Ganesan S, Acharya AS, Chauhan R, Acharya S. Prevalence and Risk Factors for Low Back Pain in 1,355 Young Adults: A Cross-Sectional Study. Asian Spine J. 2017 Aug;11(4):610-617. doi: 10.4184/asj.2017.11.4.610. Epub 2017 Aug 7.
Results Reference
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PubMed Identifier
25435683
Citation
Sung YB, Lee JH, Park YH. Effects of thoracic mobilization and manipulation on function and mental state in chronic lower back pain. J Phys Ther Sci. 2014 Nov;26(11):1711-4. doi: 10.1589/jpts.26.1711. Epub 2014 Nov 13.
Results Reference
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PubMed Identifier
30867144
Citation
Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.
Results Reference
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Citation
Khan S, Al Torairi N, Shamsi S. Comparative Study Of Snags And Maitland's Mobilization In Chronic Low Back Pain. European Journal of Physical Education and Sport Science. 2018.
Results Reference
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PubMed Identifier
31453489
Citation
Sahin N, Karahan AY, Albayrak I. Effectiveness of physical therapy and exercise on pain and functional status in patients with chronic low back pain: a randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Aug 9;64(1):52-58. doi: 10.5606/tftrd.2018.1238. eCollection 2018 Mar.
Results Reference
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PubMed Identifier
32712591
Citation
Divya, Parveen A, Nuhmani S, Ejaz Hussain M, Hussain Khan M. Effect of lumbar stabilization exercises and thoracic mobilization with strengthening exercises on pain level, thoracic kyphosis, and functional disability in chronic low back pain. J Complement Integr Med. 2020 Jul 27;18(2):419-424. doi: 10.1515/jcim-2019-0327.
Results Reference
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PubMed Identifier
32756930
Citation
Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
Results Reference
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Citation
Lim C-G. Comparison of the effects of joint mobilization, gym ball exercises, and breathing exercises on breathing pattern disorders and joint position sense in persons with chronic low back pain. Physical Therapy Rehabilitation Science. 2020;9(1):25-35.
Results Reference
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PubMed Identifier
31699077
Citation
Herman PM, Whitley MD, Ryan GW, Hurwitz EL, Coulter ID. The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain. BMC Musculoskelet Disord. 2019 Nov 7;20(1):519. doi: 10.1186/s12891-019-2904-6.
Results Reference
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Citation
Yang D, Park S, Kang J, Kim J, Jung D, Kim Y, et al. The effect of spine mobilization technique on balance and the low back pain disability index of patients with chronic back pain. Journal of The Korean Society of Integrative Medicine. 2018;6(4):139-48
Results Reference
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Effects of Cervicothoracic Mobility Program on Low Back Pain

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