Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06449261
Other study ID # IRB-COHS-FAC-134-MAY-2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2024
Est. completion date February 28, 2025

Study information

Verified date March 2024
Source Gulf Medical University
Contact Watson Arulsingh D R, PhD
Phone +971505708763
Email dr.watson@gmu.ac.ae
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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..


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date February 28, 2025
Est. primary completion date May 20, 2024
Accepts healthy volunteers No
Gender All
Age group 27 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spinal Manual therapy used in Physiotherapy Practice
C5-C6 and thoracic spine mobilization with postural correction

Locations

Country Name City State
United Arab Emirates Thumbay Hospital Ajman
United Arab Emirates Sharad Al Jurf Ajman

Sponsors (1)

Lead Sponsor Collaborator
Gulf Medical University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion of shoulder The smartphone clinometer (Plaincode Software Solutions) is readily available at low cost for several smartphones, including the iPhone, which will be used by all examiners in this study 1 Year
Primary SPADY scale In the original version, the patient was instructed to place a mark on the VAS for each item that best represented their experience of their shoulder problem over the last week [26]. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, a higher score indicating greater impairment or disability. 1 Year
Primary Cervical Range of motion Clinometer app on smartphones is a reliable and valid device for assessing cervical flexion, extension, lateral flexion, and rotation. The results from the study demonstrated moderate to excellent (ICC = .87-.96) concurrent validity in all 6 cervical movements when compared with the universal goniometric measurements 1 Year
See also
  Status Clinical Trial Phase
Completed NCT04578366 - Extracorporeal Shockwave Therapy in Long-term Functional Outcomes of Shoulder Adhesive Capsulitis N/A
Completed NCT03320200 - A Central Nervous System Focused Treatment Approach for Frozen Shoulder N/A
Completed NCT05210036 - HILT and US Therapies in Adhesive Capsulitis N/A
Enrolling by invitation NCT03705975 - Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis N/A
Completed NCT03951896 - Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder Early Phase 1
Completed NCT04347733 - Hyaluronidase in Intra-articular Steroid Injection Treating the Adhesive Capsulitis for Shoulder Phase 3
Not yet recruiting NCT06409871 - Impact of Methylxanthine Intake and Blue Light Exposure on Adhesive Shoulder Capsulitis. N/A
Completed NCT05771220 - Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis N/A
Completed NCT05810766 - Mobilization With Movement Techniques of Shoulder Girdle in Patients With Chronic Adhesive Capsulitis N/A
Recruiting NCT05384093 - Outcomes of Treatment Using the ERMI Shoulder Flexionater ® N/A
Recruiting NCT04831255 - ZILRETTAâ„¢ for Treatment of Idiopathic Adhesive Capsulitis Phase 1
Recruiting NCT04413162 - Using Kinect Motion Capture to Measure Shoulder Motion in Patients Undergoing Capsular Distension for Adhesive Capsulitis N/A
Recruiting NCT06004609 - Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder N/A
Completed NCT03090555 - Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS) N/A
Completed NCT04925128 - Effects of Moderate Physical Activity on Diabetic Adhesive Capsulitis: A Randomized Clinical Trial N/A
Completed NCT06051370 - Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Shoulder Stiffness N/A
Completed NCT05311839 - Effect of Thera Band Exercises on Adhesive Capsulitis Post Mastectomy N/A
Not yet recruiting NCT05475639 - Axillary Phonophoresis Versus Post Isometric Facilitation in the Treatment of Shoulder Adhesive Capsulitis N/A
Recruiting NCT05274698 - Efficacy Of Muscle Energy Technique On Shoulder Adhesive Capsulitis Post Mastectomy N/A
Recruiting NCT05189626 - Effectiveness of Kaltenborn Mobilizations Versus Muscle Energy Technique in Adhesive Capsulitis. N/A