- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392517
Effects of Self-mobilization Techniques in Chronic Thoracic Pain
March 31, 2023 updated by: Riphah International University
Effects of Self-mobilization Techniques on Pain, Range of Motion and Function in Patients With Chronic Pain
A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week.
Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks.
Data will be analyzed during SPSS software version 21.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic thoracic pain is pain that originates from the cervicothoracic junction and extends to the lower thoracic vertebrae.
It is caused by strain in the thoracic spine area, sustained postures of the neck and thoracic region, sitting on the computer for a long time in slouched position, or overuse of the thoracic spine.
This study aims to see the effects of the self-mobilization technique of the thoracic spine on pain, range of motion, and function in patients with chronic thoracic spine pain.
A Randomized clinical trial will be conducted at Actilife physiotherapy Rehabilitation center, Horizon Hospital Lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with the self-mobilization technique of thoracic spine and Group B will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week.
Outcome measures will be NPRS, Goniometer, and Oswestry disability index for thoracic spine after 6 weeks.
Data will be analyzed during SPSS software version 21.
After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study Type
Interventional
Enrollment (Actual)
28
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
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Actilife physiotherapy rehabilitation centre, Horizon hospital
-
-
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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic thoracic pain minimum 3 months
Exclusion Criteria:
- Soft tissues disease
- Bony disease
- Surgical history of thoracic spine
- Fracture history of thoracic spine
- Tumor
- Psychological disorders
- Traumatic injury
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
self-mobilization technique
|
Group A will be treated with self-mobilization technique of thoracic spine with the frequency of 2 sets of 10 repetitions thrice per week for a total of six weeks and conventional treatment. Self-mobilization technique will be comprised of self-mobilization technique using tennis balls and foam roller. The participant will be supine with knees in 90-degree flexion.
|
|
Other: Group B
: conventional treatment
|
Group B will be treated with the conventional treatment (heating pad, ultrasound, thoracic strengthening exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: 6th Week
|
Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain
|
6th Week
|
|
Universal Goniometer (UG)
Time Frame: 6th Week
|
It will measure range of motion of thoracic spine.
|
6th Week
|
|
Oswestry disability index
Time Frame: 6th Week
|
It is a self-reported measurement tool that measures both pain and functional status and is used for evaluating disability caused by thoracic pain.
|
6th Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
- Ortega-Santiago R, Maestre-Lerga M, Fernandez-de-Las-Penas C, Cleland JA, Plaza-Manzano G. Widespread Pressure Pain Sensitivity and Referred Pain from Trigger Points in Patients with Upper Thoracic Spine Pain. Pain Med. 2019 Jul 1;20(7):1379-1386. doi: 10.1093/pm/pnz020.
- Bikbov MM, Kazakbaeva GM, Zainullin RM, Salavatova VF, Gilmanshin TR, Arslangareeva II, Nikitin NA, Mukhamadieva SR, Yakupova DF, Panda-Jonas S, Khikmatullin RI, Aminev SK, Nuriev IF, Zaynetdinov AF, Uzianbaeva YV, Jonas JB. Prevalence of and factors associated with low Back pain, thoracic spine pain and neck pain in Bashkortostan, Russia: the Ural Eye and Medical Study. BMC Musculoskelet Disord. 2020 Feb 1;21(1):64. doi: 10.1186/s12891-020-3080-4.
- Heneghan NR, Baker G, Thomas K, Falla D, Rushton A. What is the effect of prolonged sitting and physical activity on thoracic spine mobility? An observational study of young adults in a UK university setting. BMJ Open. 2018 May 5;8(5):e019371. doi: 10.1136/bmjopen-2017-019371.
- de Vitta A, Campos LD, Bento TP, Felippe LA, Ramos WL, Fernandes JAA, et al. Thoracic Spine Pain in Adolescents and Its Association With Electronic Devices and Other Factors. 2020.
- Yamak B, İmamoğlu O, İslamoğlu İ, Çebi MJETS. The effects of exercise on body posture. 2018;13(18).
- Nakamaru K, Aizawa J, Kawarada K, Uemura Y, Koyama T, Nitta O. Immediate effects of thoracic spine self-mobilization in patients with mechanical neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):417-424. doi: 10.1016/j.jbmt.2018.05.008. Epub 2018 Jun 1.
- Puntumetakul R, Pithak R, Namwongsa S, Saiklang P, Boucaut R. The effect of massage technique plus thoracic manipulation versus thoracic manipulation on pain and neural tension in mechanical neck pain: a randomized controlled trial. J Phys Ther Sci. 2019 Feb;31(2):195-201. doi: 10.1589/jpts.31.195. Epub 2019 Feb 7.
- Kim S-j, Kim S-y, Lee M-jJPTK. The Effects of Thoracic Spine Self-mobilization Exercise Using a Tool on Pain, Range of Motion, and Dysfunction of Chronic Neck Pain Patients. 2020;27(1):1-10.
- Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
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)
May 30, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 31, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR &AHS/22/0123 Ali
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
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