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IRCT20200514047437N1 IRCT 2020-06-22 Ghurki Trust and Teaching Hospital, Lahore Effects of Medical Exercise Therapy on Pain, Range of Motion and Function in Adults with Idiopathic Adhesive Capsulitis Medical Exercise Therapy (MET) Comparison of Effectiveness of Medical Exercise Therapy (MET) with Traditional Exercises on Pain, Range of Motion and Function in Adults with Idiopathic Adhesive Capsulitis 2019-11-01 anticipated 42 Complete https://irct.ir/trial/48479 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Consecutive sampling and consecutive assignment using simple random sampling. The basic strategy used for randomization will be the development of an ordered list with group assignments made in advance using simple random sampling by random number generator. As participants enter the study, they will be given consecutive numbers and assigned to the group indicated for each number, Blinding description: The patients will be blinded from their group allocation. They will receive their allocated treatment without the knowledge of whether they belong to the control group or interventional group. The duration of the treatment session will be the same for both groups. The accessor will be a physical therapist who will have no role in the treatment of the patients in both groups. At the end, the collected data will be analyzed by a biostatistician who will be unaware of group specification of the data. N/A Adhesive shoulder capsulitis, is a term attributed to a pathological process which involves scarring and adhesion formation across the joint capsule of the glenohumeral joint. It is characterized by restricted and pain full shoulder movements which deleteriously effects the patient’s quality of life. Through out its course of disease it goes through various stages from freezing to frozen to thawing.. Intervention 1: Intervention group 1: The patients’ history and clinical tests, including muscle tests, specific joint tests, and functional tests, will be used to form the basis for choosing the right grading of the exercises, with emphasis on the appropriate weight resistance and range of motion. Patients will be instructed that the exercises might result in muscle fatigue but should not increase the shoulder pain significantly. Patient will receive directly supervised 3 sessions per week for one months. MET will consists of 7 exercises that combine global, semi global and local exercises. Global exercises involve working the whole organism dynamically, while semi-global exercising involves working an entire limb in a closed or open chain activity. Local exercises involve specifically working the affected joint, with activation of a smaller number of muscles including grade III and IV mobilizations and capsular stretching. In the attempt to establish a close to pain-free treatment, the dosage is optimized by combining global, semi-global and local exercises. The treatment will be initiated with 10–20 minutes of stationary bicycling/treadmill at a level the patient manages with a goal of ~70% of max, followed by three to four different semi-global and local exercises with three sets of 30 repetitions. After the semi-global and local exercises, the patient will performs another global exercise of 5–10 minutes of stationary bicycling/treadmill. Immediately after this, another three to four semi-global and local exercises with three sets of 30 repetitions will be performed. The treatment ends with another global exercise of 10 minutes of stationary bicycling/treadmill. Intervention 2: Conventional treatment: Patients in this group will similarly receive 3 supervised sessions per week for one month. The treatment protocol will include convention pain modulating electrotherapeutic modalities i.e. TENS and cold pack. Followed by mobilization of grade III and IV, capsular stretching, ROM and strengthening exercises of shoulder. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Maleeha Fuad
26\3 Riffle Range Road., Walton Road., Cantt
Lahore Pakistan 54750 +92 42 36603199 maleehafuad2@gmail.com Lahore Medical and Dental College scientific Maleeha Fuad
26\3 Riffle Range Road., Walton Road., Cantt
Lahore Pakistan 54750 +92 42 36603199 maleehafuad2@gmail.com Lahore Medical and Dental College Pakistan Shoulder ROM loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30°. Patients presenting with painful and restricted active and passive ROM of the affected shoulder in both elevation and rotation that occurs for at least 1 month and has either reached a plateau or worsened Patients presenting with a gradual and progressive onset of pain, at end ranges of movements of the affected shoulder. Functional activities such as reaching overhead, behind the back, or out to the side became increasingly difficult due to pain and/or stiffness. 25 years 44 years Both Patients presenting with shoulder pain and stiffness due to cerebral vascular accident, intrathoracic conditions of intra-abdominal conditions. Patients with cervical disc disease, distal extremity fracture, or self-imposed immobilization as well as patients with a known pathology of the glenohumeral joint soft tissues or structures, such as rotator cuff tendinopathy, biceps tendinopathy, calcific tendinitis, acromioclavicular or glenohumeral joint arthropathy, or proximal humeral or scapular fracture or post-operative stiffness. M75.0 Adhesive capsulitis of shoulder Rehabilitation Rehabilitation Intervention group 1: The patients’ history and clinical tests, including muscle tests, specific joint tests, and functional tests, will be used to form the basis for choosing the right grading of the exercises, with emphasis on the appropriate weight resistance and range of motion. Patients will be instructed that the exercises might result in muscle fatigue but should not increase the shoulder pain significantly. Patient will receive directly supervised 3 sessions per week for one months. MET will consists of 7 exercises that combine global, semi global and local exercises. Global exercises involve working the whole organism dynamically, while semi-global exercising involves working an entire limb in a closed or open chain activity. Local exercises involve specifically working the affected joint, with activation of a smaller number of muscles including grade III and IV mobilizations and capsular stretching. In the attempt to establish a close to pain-free treatment, the dosage is optimized by combining global, semi-global and local exercises. The treatment will be initiated with 10–20 minutes of stationary bicycling/treadmill at a level the patient manages with a goal of ~70% of max, followed by three to four different semi-global and local exercises with three sets of 30 repetitions. After the semi-global and local exercises, the patient will performs another global exercise of 5–10 minutes of stationary bicycling/treadmill. Immediately after this, another three to four semi-global and local exercises with three sets of 30 repetitions will be performed. The treatment ends with another global exercise of 10 minutes of stationary bicycling/treadmill. Conventional treatment: Patients in this group will similarly receive 3 supervised sessions per week for one month. The treatment protocol will include convention pain modulating electrotherapeutic modalities i.e. TENS and cold pack. Followed by mobilization of grade III and IV, capsular stretching, ROM and strengthening exercises of shoulder. Pain. Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: Pain will be measured using numeric rating pain scale. Functional Disability. Timepoint: Before intervention and 2, 4 weeks after intervention. Method of measurement: The Shoulder Pain and Disability Index (SPADI). Range of Motion. Timepoint: The Shoulder Pain and Disability Index (SPADI). Method of measurement: Goniometer. Ghurki Trust and Teaching Hospital, Lahore Approved 2020-01-01 Riphah College of Rehablitation Sciences (RCRS) Research Ethical Committee (REC) near Hajj Complex، I-14, Islamabad, Islamabad Capital Territory Islamabad Islamabad Capital Teritory Pakistan