Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202303495421928 Date of Approval: 08/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Adding Thoracic Manipulation on Patients with Adhesive Capsulitis.
Official scientific title The Effect of Adding Thoracic Manipulation on Patients with Adhesive Capsulitis.
Brief summary describing the background and objectives of the trial The thoracic spine and shoulder girdle including the gleno-humeral joint are biomechanically linked, with the spine providing the basis of anatomical and biomechanical functioning of the peripheral joints. With adhesive capsulitis being an inflammatory condition causing capsular restrictions and inflammatory changes in the gleno-humeral joint, an interest arises in the effect of adding manipulation of the thoracic spine to traditional conservative treatment methods on pain, function, disability scores, as well as range of motion in adults with this condition. Regional interdependence is an area of research in physical therapy receiving increased attention lately.The concept of regional interdependence refers to the idea that seemingly unrelated impairments in a remote anatomical region may contribute to, or be associated with, the patient’s primary complaint. A few studies have applied the concept of regional interdependence to patients with shoulder pain by using thoracic spine manual therapy (TSMT) for treatment, although none of them looked at frozen shoulder. The purpose of this study is to discover the effect of adding thoracic spinal manipulation to traditional conservative methods of treatment on patients with adhesive capsulitis of the shoulder. This project will be a randomized controlled clinical trial in which individuals will be randomly allocated between two groups, one receiving traditional conservative treatment consisting of modalities (heat pack), active and active assisted range of motion, mobilization with movement, and strengthening exercises along with sham manipulation and one receiving the same traditional treatment but with real thoracic spinal manipulation. Groups will have the follow outcome measures taken: • Pain according to the visual analogue scale (VAS). • Scapular motion during elevation at 90 degrees with a goniometer. • Disability and function measured with the Shoulder Pain and Disability Index (SPADI). • ROM Shoulder
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/03/2023
Actual trial start date
Anticipated date of last follow up 20/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Superficial Heat 3 times per week, at a temperature that is comfortable for the patient. 15-20 minutes each session. A superficial heat pad will be placed on the affected shoulder of the individual, to which the patient can press the button to trigger the superficial heat effect till tolerance, where releasing the button would slowly ease the heating effect. 5 Active-Treatment of Control Group
Control Group Active Assisted Range of Motion and Active Range of Motion 3 sets of 10-15 repetitions as tolerated every session, 3 times per week. A maximum of 10 minutes for the three sets. Patients will do active and active-assisted range of motion using a wand or with the assistance of the therapist in all available ranges of the glenohumeral joint, specifically trying to add range of the pattern of capsular restriction. 5 Active-Treatment of Control Group
Control Group Peripheral Joint Mobilization PJM 3 sets of 8-10 repetitions. 3 times per week. A maximum of 10 minutes. Patients will undergo PJM techniques to increase accessory motion according to the capsular restriction pattern, with the technique being conducted by a credible and capable physical therapist. The PJM technique being a manual technique that includes gliding the contact surfaces of the joint according to the concave-convex rule, and multiple grades of the glide being applied. 5 Active-Treatment of Control Group
Control Group Sham Thoracic Manipulation A single manipulation maneuver per segment. 3 times per week. Time equivalent of a single manipulation maneuver: 10-15 seconds as a maximum. The participant will lie prone, to which a certified therapist will perform a sham manipulation maneuver targetted towards the facet joints of the thoracic vertebral segments T1-T12, however the maneuver will not be actually taking place as the therapist will not provide the sufficient high velocity to produce the manipulation, instead only slight pressure will be felt by the patient. Spinal Manipulation is a manual technique utilizing high velocity and low amplitude thrusts directed at the facet joints of spinal segments to open the joints and provide further mobility. 5 Placebo
Experimental Group Thoracic Spine Thrust Manipulation high velocity, low amplitude for 12 weeks, 3 times per week The manipulation group received the manipulation (high velocity, low amplitude), which was performed by a physical therapist with the subject in the supine position and with the arms crossed over the chest and hands passed over the shoulders 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Individuals with adhesive capsulitis. 2. Ages between 40 and 60 years. 3. In phase 2 and 3 of adhesive capsulitis. 4. No medical treatment other than analgesics for the past 3 months. 5. Has not taken corticosteroid injections. 1. Previous shoulder or thoracic spinal surgery. 2. Recent history of trauma or fracture. 3. Osteoporosis. 4. Myelopathy. 5. Cervical radiculopathy. 6. Debilitating or mental diseases. 7. Presence of any contraindication for manipulation. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/06/2022 Research ethical committee Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - , Giza District, 11432, Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain according to the visual analogue scale (VAS). Baseline, after initial visit, after 6 weeks, and lastly after 12 weeks
Primary Outcome Scapular motion during elevation at 90 degrees with a goniometer. Baseline, after initial visit, after 6 weeks, and lastly after 12 weeks
Primary Outcome Disability and function measured with the Shoulder Pain and Disability Index (SPADI). Baseline, after initial visit, after 6 weeks, and lastly after 12 weeks
Secondary Outcome Range of motion of the shoulder including: Abduction, Flexion, External rotation, Internal rotation both actively and passively. Baseline, after initial visit, after 6 weeks, and lastly after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Physiotherapy clinic Cairo university El-Tahrir st. - in front of Ben El- Sarayat Traffic - , Giza District, 11432, Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Ahmad El Melhat 13 town vally, Giza Egypt Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Ahmad El Melhat 13 TOWN Vally , Giza EGYPT Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Rami Abbas Al-Mazraa, Cola Square, Shams BeirutBuilding,Bloc B, 12thfloor. Beirut Lebanon
Mr. Moustafa Zebdawi Nouaireh Street Beirut Lebanon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad El Melhat a.melhat@bau.edu.lb +201112595022 13 town vally ,giza
City Postal code Country Position/Affiliation
Egypt Egypt PhD in Physical Therapy
Role Name Email Phone Street address
Public Enquiries Moustafa Zebdawi zebdawimoustafa@gmail.com +96181962755 Nouaireh
City Postal code Country Position/Affiliation
Beirut Lebanon BSc. In Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Ahmad El Melhat a.melhat@bau.edu.lb +201112595022 13 town vally ,giza
City Postal code Country Position/Affiliation
giza Egypt PhD In Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results of the study after de identification as texts and tables. Statistical Analysis Plan One year after publication. Controlled access through authors mail.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information