NCT06049264

Brief Summary

This project will be a Randomized clinical trial conducted to compare Short-term effects of thoracic spine manual traction with mobilization and Thoracic manipulation in patients with mid thoracic pain and pseudo visceral symptoms. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Sehat Medical complex, Lahore. Eligibility criteria will be Age group between 20 to 40 years both male and female genders with mid thoracic pain having pseudo visceral symptoms. Referred by physician after exclusion of post-surgical condition from past 6 months Neurological, Pulmonological, Cardiac, Musculoskeletal and Esophageal conditions. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Thoracic spine manual traction with mobilization, Group B participants will be given baseline treatment along with Thoracic manipulation protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Revised Oswestry thoracic pain disability questionnaire (ODI) and Inclinometer to measure ROM of Thoracic spine,3 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

ManipulationMobilizationPseudo visceral symptomsPainSpinal Traction

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    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.

    4th Week

  • Revised Oswestry thoracic pain disability questionnaire for disability

    This questionnaire is designed to evaluate Level of Disability in thoracic Pain patients. Disability was measured using the Oswestry Disability Index (ODI: range 0-no disability to 50-maximum disability possible). The ODI is a commonly used outcome measure amongst LBP patient.

    4th Week

  • Inclinometer measurement of Thoracic ROM

    Inclinometers are portable, lightweight, and inexpensive pieces of equipment that are used to measure range of motion, like goniometry. Inclinometers are typically found in clinics and are used as a part of a physical examination. An intraclass correlation coefficient (ICC) was found to be between 0.87-0.95.

    4th Week

Study Arms (2)

Thoracic Spine Manual Traction with Mobilization

EXPERIMENTAL

Thoracic Spine Manual Traction with Mobilization

Other: Thoracic spine manual traction with mobilization protocol.

Thoracic Spine Manual Traction with Manipulation

ACTIVE COMPARATOR

Thoracic Spine Manual Traction with Manipulation

Other: Thoracic manipulation protocol

Interventions

The therapist will perform one 30-second bout of grade I or II central posterior-anterior mobilization at the T3 spinous process as described by Maitland et al. After the 30-second bout, the therapist proceeded to T4 and performed the same technique. This process was continued sequentially in a caudal direction to T8, for an overall intervention time of approximately 3 minutes. In addition to mobilization, thoracic spine traction will be also given in sitting position.

Thoracic Spine Manual Traction with Mobilization

To perform the manipulation, the stabilizing hand will be placed at the level immediately caudal to the restricted segment using a ''pistol grip''. Once the pre manipulative position will be achieved the patient will be instructed to take a deep inhalation and exhale. During the exhalation the treating clinician performed a high velocity, small amplitude thrust in a direction to facilitate relative closing or opening of the respective facet joint as indicated by the segmental examination.

Thoracic Spine Manual Traction with Manipulation

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group between 20 to 40 years
  • Both male and female gender.
  • Mid thoracic pain with pseudo visceral symptoms.
  • Participants with moderate and severe pain as ODI score should be within range of 30% to 68%.

You may not qualify if:

  • Post-surgical condition (6 months)
  • Neurological Conditions
  • Pulmonological conditions
  • Cardiac conditions such as angina pectoris, coronary artery disease, Arrhythmia, pericarditis or aortic aneurysm.
  • Musculoskeletal disorders
  • Esophageal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Hanjarwal Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (11)

  • Izzo R, Popolizio T, D'Aprile P, Muto M. Spinal pain. Eur J Radiol. 2015 May;84(5):746-56. doi: 10.1016/j.ejrad.2015.01.018. Epub 2015 Feb 13.

    PMID: 25824642BACKGROUND
  • Briggs AM, Smith AJ, Straker LM, Bragge P. Thoracic spine pain in the general population: prevalence, incidence and associated factors in children, adolescents and adults. A systematic review. BMC Musculoskelet Disord. 2009 Jun 29;10:77. doi: 10.1186/1471-2474-10-77.

    PMID: 19563667BACKGROUND
  • Romanchuk O. The Immediate Effects of the Manual Therapy Traction Manipulations on Parameters of Cardiorespiratory System Functioning. International Journal of Human Movement and Sports Sciences. 2022;10(4):832-40.

    BACKGROUND
  • Morningstar MW. Cervical hyperlordosis, forward head posture, and lumbar kyphosis correction: A novel treatment for mid-thoracic pain. J Chiropr Med. 2003 Summer;2(3):111-5. doi: 10.1016/S0899-3467(07)60055-X.

    PMID: 19674605BACKGROUND
  • Manchikanti L, Singh V, Pampati V, Beyer CD, Damron KS. Evaluation of the prevalence of facet joint pain in chronic thoracic pain. Pain Physician. 2002 Oct;5(4):354-9.

    PMID: 16886012BACKGROUND
  • Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.

    PMID: 32778081BACKGROUND
  • Cleland JA, Flynn TW, Childs JD, Eberhart S. The audible pop from thoracic spine thrust manipulation and its relation to short-term outcomes in patients with neck pain. J Man Manip Ther. 2007;15(3):143-54. doi: 10.1179/106698107790819828.

    PMID: 19066662BACKGROUND
  • . Fryer G, Carub J, McIver S. The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine. Journal of Osteopathic Medicine. 2004;7(1):8-14.

    BACKGROUND
  • Vicenzino B, Collins D, Wright A. The initial effects of a cervical spine manipulative physiotherapy treatment on the pain and dysfunction of lateral epicondylalgia. Pain. 1996 Nov;68(1):69-74. doi: 10.1016/S0304-3959(96)03221-6.

    PMID: 9252000BACKGROUND
  • Park SJ, Kim SH, Kim SH. Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study. Healthcare (Basel). 2020 Sep 2;8(3):316. doi: 10.3390/healthcare8030316.

    PMID: 32887287BACKGROUND
  • Anandkumar S M Sc Pt Bpt C-Ompt Cafs Cert Dnt, Manivasagam M Bpt Dyt Comt Fsr Dnp Ces. Effect of fascia dry needling on non-specific thoracic pain - A proposed dry needling grading system. Physiother Theory Pract. 2017 May;33(5):420-428. doi: 10.1080/09593985.2017.1318423. Epub 2017 May 8.

    PMID: 28481688BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

September 25, 2023

Primary Completion

January 10, 2024

Study Completion

January 15, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations