Effectiveness of Dry Needling on Pain and Function for the Management of Shoulder Adhesive Capsulitis: a Randomized Controlled Trial

Shoulder adhesive capsulitis is reported to affect 2% to 5% of the general population. The clinical course of adhesive capsulitis has been described in the literature ranging from 18-24 months, with persistent symptoms often lasting longer after range of motion has returned. Fifty percent of individuals will report having mild pain or stiffness at 7-year follow up. Treatment for adhesive capsulitis can be extensive with the average duration of treatment being 4.7 months. In general, adhesive capsulitis is often thought of as a self limiting diagnosis that significantly impacts a patients function and livelihood. Physical therapists often prescribe exercise for the management of adhesive capsulitis including stretching and strengthening. There is some support for exercise to provide moderate improvements in function, mobility, and decreased pain but impairments including pain and range of motion deficits persist even with exercise treatments.

Trigger point dry needling is a treatment approach often used by physical therapists that has been purported to be effective for reducing pain and improving range of motion along with improving function. Improvements in range of motion are associated with improvements in function for patients with adhesive capsulitis. While dry needling does not directly treat the tissues thought to be the primary factor in limiting range of motion, it does treat the surrounding tissues, including trigger points, that have been associated with painful shoulders including adhesive capsulitis. However, the direct investigation of dry needling for shoulder adhesive capsulitis has been minimally investigated. While published papers on dry needling for adhesive capsulitis exists, they are primarily case reports or case series. The growth in utilization of dry needling as a treatment option with minimal evidence creates a dilemma in practice.

This will be a single blinded randomized controlled trial comparing dry needling with exercise versus sham dry needling and exercise for subjects with shoulder pain consistent with adhesive capsulitis.

Patients undergoing physical therapy examination for adhesive capsulitis will be considered for participation in the study. If the evaluating/treating physical therapist deems that the patient may be appropriate for the study, he/she will approach the patient to gauge interest in participating in the study. If the patient expresses interest, he or she will be referred to a member of the study personnel (dry needling physical therapist) who will screen for the inclusion and exclusion criteria. The study personnel will provide additional details regarding the study requirements. The consent process may be initiated at this time or deferred to a later time if the patient requests additional time to consider participation. After consenting, the patient will be randomly assigned to one of the two treatment groups. A digital coin flip (Siri) will be used for randomization procedures to determine the group allocation (dry needling and exercise or sham dry needling and exercise). Exercise prescription will be prescribed pragmatically. These will be based on the individual patient examination and re-examination findings by the treating physical therapists, and supported by best evidence. These exercises will address strength, flexibility and postural impairments based on the clinical examination. The treating physical therapist will be blinded to the dry needling treatment group assigned. The study personnel physical therapist will be blinded to the outcomes.

For subjects that are randomized to the group receiving trigger point dry needling, active and latent trigger points as described in previous protocols for dry needling of the shoulder will be used to determine the appropriate muscles to treat. The study personnel physical therapist will perform the dry needling (dry needling physical therapists). All dry needling physical therapists have had considerable and appropriate training in trigger point dry needling. Clean needle techniques will be applied including use of gloves by the physical therapist and chlorhexidine wipes (or alcohol wipes if a chlorhexidine allergy is known) for skin preparation. The dry needling procedure will involve using a sterile packaged Seirin ® 30-60 mm .25-.36 J-type monofilament needle. Palpation of the active or latent trigger point will direct the study personnel as to where to treat. The needle will be inserted using an insertion tube. Pistoning and twisting of the needle will be performed to elicit a local twitch response. The study personnel will document the muscle treated, if a local twitch response occurred, and if it was an active or latent trigger point. The frequency of dry needling sessions will be determined in part by the dry needling physical therapist as well as the subject. Subjects who defer subsuquent dry needling treatments will be noted accordingly in the database.