NCT05392517

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

March 31, 2023

Conditions

Keywords

manual therapypainRange of motion

Outcome Measures

Primary Outcomes (3)

  • 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

  • Universal Goniometer (UG)

    It will measure range of motion of thoracic spine.

    6th Week

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

self-mobilization technique

Other: self-mobilization technique along with conventional therapy

Group B

OTHER

: conventional treatment

Other: conventional therapy

Interventions

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.

Group A

Group B will be treated with the conventional treatment (heating pad, ultrasound, thoracic strengthening exercises

Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic thoracic pain minimum 3 months

You may not qualify if:

  • Soft tissues disease
  • Bony disease
  • Surgical history of thoracic spine
  • Fracture history of thoracic spine
  • Tumor
  • Psychological disorders
  • Traumatic injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Actilife physiotherapy rehabilitation centre, Horizon hospital

Lahore, Punjab Province, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 30821833BACKGROUND
  • 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.

    PMID: 32007098BACKGROUND
  • 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.

    PMID: 29730619BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 28750310BACKGROUND
  • Yamak B, İmamoğlu O, İslamoğlu İ, Çebi MJETS. The effects of exercise on body posture. 2018;13(18).

    BACKGROUND
  • 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.

    PMID: 31103129BACKGROUND
  • 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.

    PMID: 30858662BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32762708BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil-ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations