Thoracic Spine Manual Traction With Mobilization Versus Manipulation

January 28, 2024 updated by: Riphah International University

Short-term Effects of Thoracic Spine Manual Traction With Mobilization Versus Thoracic Manipulation in Patients With Mid Thoracic Pain and Pseudo Visceral Symptoms

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal pain is a well-recognized condition associated with significant personal and community burdens. Compared to the lumbar and cervical spine, the thoracic spine has received less attention in terms of clinical, genetic and epidemiologic research, yet pain experienced in the thoracic spine can be equally disabling, imposing similar burdens on the individual, community and workforce. Pseudo visceral symptoms refer to physical sensations or symptoms that mimic those associated with underlying medical condition affecting the internal organs, but without any organic cause or pathology. Manipulation and mobilization are two manual techniques that are commonly used by osteopaths, chiropractors and physiotherapists to treat spinal pain and dysfunction. This study aims 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.

This randomized clinical trial will be conducted at Sehat medical complex, Lahore. It will include patients with age group between 20 to 40 years, both male and female gender with mid thoracic pain and pseudo visceral symptoms referred by physician after exclusion of visceral symptoms. Those patients with post-surgical condition from past 6 months, Neurological, Pulmonological or Cardiac conditions will be excluded. Participants will be divided into two groups. Group A will receive of thoracic spine manual traction with mobilization treatment protocol and Group B will receive Thoracic manipulation protocol. Both groups will receive baseline treatment including TENS and Hot pack. Short term effects would be assessed after treatment for 4 weeks. Patients will be assessed by Numeric pain rating scale, Inclinometer and Revised Oswestry thoracic pain disability questionnaire. The findings can contribute to the growing evidence based supporting whether the use of thoracic spine manual traction with mobilization or Thoracic manipulation improve pain, ROM and disability in patients with mid thoracic pain and pseudo visceral symptoms. Analysis will be done by statistical package for social sciences SPSS 29.

Study Type

Interventional

Enrollment (Actual)

34

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Sehat Medical Complex, Hanjarwal Lahore

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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%.
  • Referred by physician after exclusion of visceral symptoms

Exclusion Criteria:

  • 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thoracic Spine Manual Traction with Mobilization
Other: Thoracic spine manual traction with mobilization protocol.
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.
Active Comparator: Thoracic Spine Manual Traction with Manipulation
Other: Thoracic manipulation protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclinometer measurement of Thoracic ROM
Time Frame: 4th Week
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
Numeric Pain Rating Scale
Time Frame: 4th Week
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
Time Frame: 4th Week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Syed Shakil ur Rehman, Riphah International University, Lahore

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

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)

September 25, 2023

Primary Completion (Actual)

January 10, 2024

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0132 Feroza

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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