Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-30 @ 4:29 AM
Study NCT ID:
NCT06449261
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy of Spine With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Randomised Clinical Trial
Sponsor:
Gulf Medical University
Organization:
Study Overview
Official Title:
C5-C6 and Thoracic Spine Mobilization With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Two-group, Parallel-arm, Single-blinded, Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.
Detailed Description:
Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.
Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..
Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: