Clinical Trials Logo

Clinical Trial Summary

this study to detect the effect of pulsed radiofrequency to the suprascapular nerve in treating chronic pain and to evaluate range of motion of shoulder joint after the intervention


Clinical Trial Description

Adhesive capsulitis (also known as frozen shoulder) is a painful and disabling disorder of unclear cause in which the shoulder capsule, the connective tissue surrounding the glenohumeral joint of the shoulder, becomes inflamed and stiff, greatly restricting motion and causing chronic pain. Pain is usually constant, worse at night, and with cold weather. Certain movements or bumps can provoke episodes of tremendous pain and cramping. The condition is thought to be caused by injury or trauma to the area and may have an autoimmune component.

Frozen shoulder patients usually present in the sixth decade of life, and onset before the age of 40 is very uncommon. The peak age is 56, and the condition occurs slightly more often in women than men In 6-17% of patients, the other shoulder becomes affected, usually within five years, and after the first has resolved .The non-dominant shoulder is slightly more likely to be affected. Few attempts have been made to calculate the cumulative lifetime risk of frozen shoulder. In the Scandinavian population at risk, it has been estimated at a minimum of 2% per year. Recurrence is highly unusual.Frozen shoulder can be a primary or idiopathic problem or it may be associated with another systemic illness. By far the most common association of a secondary frozen shoulder is diabetes mellitus. The incidence of frozen shoulder in diabetes patients is reported to be 10%-36%. The incidence in type 1 and type 2 diabetes is similar.Unfortunately, frozen shoulder in diabetes is often more severe and is more resistant to treatment . The natural history of the diabetic painful stiff shoulder and found a restriction in the range of motion in 35 (65%) of 54 shoulders at a mean follow-up of 29 months . There is an association with Dupuytren's disease in the hand, proposing that the contracting shoulder tissue itself represents a form of fibromatosis . Much more rarely, secondary frozen shoulder may be associated with conditions such as hyperthyroidism hypothyroidism and hypoadrenalism. Additional associations include Parkinson's disease, cardiac disease, pulmonary disease, and stroke although the pathological condition here may be different from idiopathic frozen shoulder. Clearly, in the case of stroke, shoulder stiffness may be simply the result of muscle spasticity in the shoulder region.Frozen shoulder has also been reported subsequent to non-shoulder surgical procedures, such as cardiac surgery cardiac catheterisation through the brachial artery neurosurgery and radical neck dissection .

The stages of frozen shoulder are 3 stages Freezing In the "freezing" stage, the patient slowly has more and more pain. As the pain worsens, the shoulder loses range of motion. Freezing typically lasts from 6 weeks to 9 months.

Frozen Painful symptoms may actually improve during this stage, but the stiffness remains. During the 4 to 6 months of the "frozen" stage, daily activities may be very difficult.

Thawing Shoulder motion slowly improves during the "thawing" stage. Complete return to normal or close to normal strength and motion typically takes from 6 months to 2 years.

Movement of the shoulder is severely restricted, with progressive loss of both active and passive range of motion The condition is sometimes caused by injury, leading to lack of use due to pain, but also often arises spontaneously with no obvious preceding trigger factor (idiopathic frozen shoulder). Rheumatic disease progression and recent shoulder surgery can also cause a pattern of pain and limitation similar to frozen shoulder. Intermittent periods of use may cause inflammation.

One sign of a frozen shoulder is that the joint becomes so tight and stiff that it is nearly impossible to carry out simple movements, such as raising the arm. The movement that is most severely inhibited is external rotation of the shoulder.

In frozen shoulder, there is a lack of synovial fluid, which normally helps the shoulder joint, a ball and socket joint, move by lubricating the gap between the humerus(upper arm bone) and the socket in the shoulder blade. The shoulder capsule thickens, swells, and tightens due to bands of scar tissue (adhesions) that have formed inside the capsule. As a result, there is less room in the joint for the humerus, making movement of the shoulder stiff and painful. This restricted space between the capsule and ball of the humerus distinguishes adhesive capsulitis from a less complicated, painful, stiff shoulder .

Frozen shoulder generally gets better over time, although it may take up to 3 years.The focus of treatment is to control pain and restore motion and strength through physical therapy.

Nonsurgical Treatment More than 90% of patients improve with relatively simple treatments to control pain and restore motion.

Non-steroidal anti-inflammatory medicines. Drugs like aspirin and ibuprofen reduce pain and swelling.

Steroid injections. Cortisone is a powerful anti-inflammatory medicine that is injected directly into shoulder joint.

Physical therapy. Specific exercises will help restore motion. These may be under the supervision of a physical therapist or via a home program. Therapy includes stretching or range of motion exercises for the shoulder. Sometimes heat is used to help loosen the shoulder up before the stretching exercises.

Surgical Treatment If symptoms are not relieved by therapy and anti-inflammatory medicines, surgery may be considered.

The goal of surgery for frozen shoulder is to stretch and release the stiffened joint capsule. The most common methods include manipulation under anesthesia and shoulder arthroscopy.

Manipulation under anesthesia. During this procedure shoulder will be forced to move which causes the capsule and scar tissue to stretch or tear. This releases the tightening and increases range of motion Shoulder arthroscopy. In this procedure, the surgeon will cut through tight portions of the joint capsule. This is done using pencil-sized instruments inserted through small incisions around the shoulder In many cases, manipulation and arthroscopy are used in combination to obtain maximum results. Most patients have very good outcomes with these procedures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03456531
Study type Interventional
Source Assiut University
Contact yasmeen elmasry, RD
Phone 01093910848
Email yasmeen1992.ye@gmail.com
Status Not yet recruiting
Phase N/A
Start date March 15, 2018
Completion date March 1, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04747938 - Frozen Shoulder Treated by Energy Accumulator N/A
Recruiting NCT05979974 - High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder N/A
Completed NCT02169206 - Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position N/A
Enrolling by invitation NCT03861923 - Dry Needling for Shoulder Adhesive Capsulitis N/A
Not yet recruiting NCT05956171 - The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder N/A
Completed NCT03320200 - A Central Nervous System Focused Treatment Approach for Frozen Shoulder N/A
Recruiting NCT04738253 - Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
Not yet recruiting NCT06129006 - Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder N/A
Completed NCT02944526 - The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial Phase 4
Recruiting NCT02283996 - Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment Phase 4
Completed NCT02006719 - Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT01483963 - AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT04369144 - Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder N/A
Completed NCT03951896 - Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder Early Phase 1
Completed NCT05993000 - Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial N/A
Completed NCT05372497 - Central Nervous System Focused Therapy in Frozen Shoulder N/A
Completed NCT04044196 - Preoperative Psychological Risk Factors for the Retractable Capsulitis of the Shoulder After Shoulder Rotator Cuff Repair Surgery