Additional Effects of Thoracic Manipulation in Adhesive Capsulitis.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the additional effects of thoracic manipulation on pain and restricted shoulder mobility and reducing disability in patients with adhesive capsulitis. A randomized control trail is conducting at Helping hand institute of rehabilitation sciences Mansehra. Patients diagnosed with frozen shoulder were randomized into 2 groups i.e. Group A (n=16) and Group B(n=16) with the help of lottery method. Group A would receive conventional therapy including hot pack, transcutaneous electrical nerve stimulation, stretches and facilitation techniques Group B would receive thoracic manipulation along with hot pack and TENS, stretches and facilitation techniques. The total treatment time is 2 weeks with three sessions per week making a total of 6 sessions. Baseline assessment on 1st visit. 2nd assessment on 6th visit. 3rd assessment on follow up after 3 weeks would be done. The study duration is 6 months. Purposive non probability sampling technique applied. Only 40 to 60 years participants with adhesive capsulitis are including in this trial. Tools use in this study are visual analogue scale (VAS), bubble inclinometer and (disability of arm, shoulder and hand) questionnaire. Data analyzed through statistical package of social sciences version 25.

Detailed Description
-----------------
Frozen shoulder is a widespread disabling condition which causes significant disability. In spite of hundred years of treating this condition the clarity, diagnosis, pathology and most effectual treatments are still need to be explored.It is characterized by the impulsive onset of pain, inflexibility and restricted range of motion at the shoulder joint. The pathophysiology of frozen shoulder is not exactly known. However it is generally supposed that a combination of contracture of capsule, rotator cuff tendon fibrosis, sub-scapular depression and the coraco-humeral ligament lead to comprehensive movement restriction at the glenohumeral joint. Frozen shoulder is considered to have an occurrence of 3%-5% in the common population and up to 20% in those with diabetes mellitus. Between the ages of 40 and 60 it is most prevalent and is almost not found in ages below that and in persons who work manually. It is somewhat more common in women then man. Bilateral frozen shoulder occurs in 14% of population and up to 20% of population will develop some degree of related symptoms in the other shoulder. the most common associated risk factor for developing the frozen shoulder is diabetes mellitus, and a patient with diabetes has 10%-20% risk of developing frozen shoulder. Thoracic spine manipulation has received growing attention in treating the patients with shoulder pain. Recent studies have shown that thoracic manipulation is an effective combination therapy for patients with shoulder pain. The position of thoracic spine significantly have an effect on shoulder joint and shoulder kinematics during movement on different planes as there is decreased muscle force when a person is in a slouch position. Thoracic Spine manipulation is a treatment choice by the number of health professionals especially the physical therapist. Literature defines thoracic manipulation as highly practiced and skilled passive thrust to joints and adjacent structures and soft tissues at variable intensity consisting of small amplitude and high velocity therapeutic movements at thoracic spine including cervicothoracic junction. Much of the recent studies are focusing on the relationship of thoracic spine to other body regions such as neck and shoulder rather than thoracic spine itself this phenomenon is described as regional interdependence.although cervical spine manipulation has also improve pain and disability in patients with non-specific shoulder pain but have some evidence of thrust complications relating to cervical spine. Similar neurophysiologic associations are documented with thoracic spine manipulation in relation with shoulder pain with less complications and thrust risk. Spinal manipulation of the thoracic spine can be an effective intervention for treating patients with shoulder pain or dysfunctions. Treatment protocols focusing the thoracic spine must be added to the intervention of rehabilitation of patients with shoulder pain in clinical practice. In common clinical practice a series of thoracic hypomobility has been noticed at the T1-T3 spinal segments or the T3-T5 segments in patients with shoulder pathologies. In literature manipulation of thoracic regions has been shown to produce improvement in upper extremity blood flow and circulation. Researches related to thoracic spine manipulation is signifying a association between manipulation of the thoracic spine and enhancement in shoulder function and potency. Thus the purpose of the study is to evaluate the possible effect of thoracic manipulation on shoulder range of motion and function in combination with conventional intervention for the individuals with frozen shoulder. Thoracic spine thrust manipulation provided a statistically significant decrease in self-reported pain measures and disability in patients with Shoulder impingement syndrome. Thoracic spine and upper rib manipulative therapy is associated with improvement in shoulder pain and ROM immediately following intervention in patients with a primary complaint of shoulder pain. Thoracic spine manual therapy accelerated recovery and reduced pain and disability in patients having nonspecific shoulder pain (NSSP). Thoracic and rib manipulation is effective in relieving pain and improving range of motions and reducing disability in frozen shoulder patients. Cervical thoracic junction and upper thoracic spine manipulations in combination with traditional physical therapy will decrease pain, increase range of motion, and increase function in patients suffering from internal impingement syndrome more than patients who received traditional physical therapy treatment and posterior and inferior mobilization.

Official Title
-----------------
Additional Effects of Thoracic Manipulation in Patients With Adhesive Capsulitis.

Conditions
-----------------
Frozen Shoulder

Intervention / Treatment
-----------------
* Other: Thoracic manipulation
* Other: Conventional physical therapy Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adhesive capsulitis (Stage II and III) Bilateral or unilateral involvement Thoracic spine hypomobility Exclusion Criteria: Any previous Surgery on the affected shoulder. Recent trauma to shoulder complex. Thoracic outlet syndrome. Cervical symptoms (tingling, numbness). Rotator cuff tears of affected shoulder. Fractures involving shoulder complex. Osteoporosis of spine. Ankylosing spondylitis

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracic manipulation<br>additional thoracic manipulation along with hotpack, transcutaneous electrical nerve stimulation ,serratus anterior,pectoralis major,minor, posterior capsular stretches.. | Other: Thoracic manipulation<br>* hot pack ,transcutaneous electrical nerve stimulation and manipulation along with stretching'<br>|
| Active Comparator: Conventional Physical Therapy Program<br>hot pack transcutaneous electrical nerve stimulation, serratus,anterior,pectoralis major, minor, posterior capsular stretches. | Other: Conventional physical therapy Program<br>* hot pack ,transcutaneous electrical nerve stimulation and stretching<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS): | Visual analogue scale is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words no pain and worst pain at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity. Changes from the baseline will be measured and at 4th week and then at 6th week | 3 weeks | 
| Bubble Inclinometer | Bubble Inclinometer is used to measure range-of-motion (ROM). | 3 weeks | 
| (Disabilities of the Arm, Shoulder and Hand) questionnaire: | The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frozen Shoulder, Thoracic Manipulation