Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.

Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?

The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up

Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the shoulder joint. There exist different clinical trial related to this pathology, however a lack of information of both efficacy and methodology used in manual therapy treatment remains unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the improvement after different conservative treatments is also unknown. Besides, little is known about which factors are more correlated with pain and function.Thus, biomechanic and psychosocial factors together with ultrasound measurements and blood glucose concentration (see "outcome and secondary measures" section ) will be analyzed before and after the treatment, with a nine months follow up. Results will be spread showing short term effects and long term effects in different publications.

Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose concentration, before and after the treatments proposed with a nine months follow up.

Method

This study is designed as a clinical trial, with two randomised parallel groups comparing two different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It will be carried out in different Hospital and primary care centers where patients suffering from adhesive capsulitis of the shoulder will be asked to participate in the project. If participants are eligible then they will be include in the study. All participants will have to sign informed consent after be shown about the whole project as by written (informative sheet) as by speech from the physiotherapist in charge.

Once include in the study definitely, all factors detailed (see "outcome measures" section) will be measured. Also, every factor will be correlated with shoulder pain and function. This way, the investigators could predict which factor are more correlated with. Furthermore, if significant correlations are found, such factors could be used as predictors or monitoring tool when patients with shoulder adhesive capsulitis are treated

Inclusion Criteria:

• People suffering from adhesive capsulitis as indicated by passive range of motion loss >25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.

Exclusion Criteria:

• Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
• Corticoid injections during the six months prior to the study
• Analgesic-antiinflammatory medication intake during the intervention phase of the study.