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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392517
Other study ID # REC/RCR &AHS/22/0123 Ali
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date January 30, 2023

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
self-mobilization technique along with conventional therapy
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. Mobilization Technique 1: Cross your arms over your chest so that you are in slight flexion and then slowly begin to move your shoulders and head closer to the floor placing the mid back into extension over the balls joined to make mobilization device. Hold this position for 3 seconds and then return to the flexed position. Mobilization Technique 2: Lying lengthwise on the foam roller, clasp your hands together in front of you, above your chest with arms straight. Slowly move your arms above your head until you feel a good stretch. This exercise should be pain free. Hold stretch for 30- 60 seconds.
conventional therapy
Group B will be treated with the conventional treatment (heating pad, ultrasound, thoracic strengthening exercises

Locations

Country Name City State
Pakistan Actilife physiotherapy rehabilitation centre, Horizon hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

Yamak B, Imamoglu O, Islamoglu I, Çebi MJETS. The effects of exercise on body posture. 2018;13(18).

Outcome

Type Measure Description Time frame Safety issue
Primary NPRS 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
Primary Universal Goniometer (UG) It will measure range of motion of thoracic spine. 6th Week
Primary Oswestry disability index 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
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