Clinical trial NCT06049264: Thoracic Spine Manual Traction With Mobilization Versus Manipulation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic
Keywords: Manipulation
Mobilization
Pseudo visceral symptoms
Pain
Spinal Traction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4th Week
measure: Revised Oswestry thoracic pain disability questionnaire for disability
timeFrame: 4th Week
measure: Inclinometer measurement of Thoracic ROM
timeFrame: 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sehat Medical Complex, Hanjarwal Lahore
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore
name: Syed Shakil ur Rehman
role: PRINCIPAL_INVESTIGATOR
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