Clinical trial NCT06449261: Manual Therapy of Spine With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Randomised Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 66
Sex: ALL
Minimum age (years): 27
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-group, parallel-arm, single-blinded, randomized clinical trial
Primary purpose: TREATMENT

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..

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with AC \& a Positive for Apley's scratch test.
* Adhesive capsulitis (with symptoms for at least three months and less than 12 months\[18\]
* Both Gender
* Age 27-70
* Sleep-disturbing night pain

Exclusion Criteria:

* Patients who are unwilling to participate
* patients with malignancy
* AC Secondary to fracture and uncontrolled hypertension.
* Unstable cardiac conditions
* Patient with neurological conditions
* Patient with reported concurrent cervical issues

Primary outcomes:
measure: Range of motion of shoulder
timeFrame: 1 Year
measure: SPADY scale
timeFrame: 1 Year
measure: Cervical Range of motion
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Al Jurf
country: United Arab Emirates
facility: Sharad
state: Ajman
city: Ajman
country: United Arab Emirates
facility: Thumbay Hospital
Study officials:
affiliation: Gulf Medical University
name: Watson Arulsingh D R, PhD
role: PRINCIPAL_INVESTIGATOR
References: