Thoracic Spine Manual Traction With Mobilization Versus Manipulation

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06049264

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracic	Other: : baseline physical therapy treatment along with Thoracic spine manual traction with mobilization protocol. Other: baseline physical therapy treatment along with Thoracic manipulation protocol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mobilization Thoracic Spine Manual Traction with Mobilization	Other: : baseline physical therapy treatment along with 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: Manipulation Thoracic Spine Manual Traction with Manipulation	Other: baseline physical therapy treatment along with 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.

Arm

Intervention/Treatment

Experimental: Mobilization

Thoracic Spine Manual Traction with Mobilization

Other: : baseline physical therapy treatment along with 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: Manipulation

Thoracic Spine Manual Traction with Manipulation

Other: baseline physical therapy treatment along with 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.

Outcome Measures

Primary Outcome Measures

NPRS [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.
Revised Oswestry thoracic pain disability questionnaire for disability [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 patients and is reported to be a valid, reliable and responsive hence suitable as a clinical measure. Test-retest reliability has been shown to be high, a study by Fairbank et al recorded values ranging from = 0.83 to 0.99 that can vary over a given period of time. Each item consists of 6 statements with Each item is scored on a 0---5 scale, and the maximum score is 50.
Inclinometer measurement of Thoracic ROM [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 from past 6 months
Neurological Conditions such as SLE, Herpes zoster, parkinsonism, Shingles disease.
Pulmonological conditions like, pneumonia or pneumothorax.
Cardiac conditions such as angina pectoris, coronary artery disease, Arrhythmia, pericarditis or aortic aneurysm.
Musculoskeletal disorders like Scheuermann's disease, osteoporosis, TB of spine, Ankylosing spondylitis, malignancy, rib cage deformity, kyphosis or scoliosis.
Esophageal disorders