Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Derek Clewley, DPT, PhD|
|Principal Investigator Affiliation||Duke University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Enrolling by invitation|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Shoulder Adhesive Capsulitis, Shoulder Pain, Frozen Shoulder|
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. For subjects that are randomized to the group receiving sham dry needling group, the assessment procedure will be the same as the dry needling group. The same clean approach to needling will be performed in order to mimic the procedure of actual trigger point dry needling. Palpation of the active or latent trigger point will direct where to treat. The dry needling physical therapists will be trained by the principal investigator on the sham dry needling technique. A finishing nail cleaned with sterile alcohol swab will be inserted into a tube with the tip of the nail extended out the end of the tube. The physical therapist will use this sham needle over the area of the trigger point without skin penetration. The finishing nail provides a minimal sharp sensation that is sometimes felt by patients receiving dry needling. It also matches the potential perception that a patient has regarding receiving any needle treatments. The force of the sham (finishing nail) treatment will be just enough to produce a slight sharp sensation. The tap provided is just enough so that the patient perceives a light sharp sensation. The procedure is set up similarly to actual dry needling in that the physical therapist uses the same finger and holding position of the tube. After the tap of the finishing nail, pseudo pistoning of the tube only (not the nail) will be performed to match the duration of treatment time of actual dry needling. This will range from 2 to 10 pistons varied per patient per muscle to match the approach of actual trigger point dry needling. Furthermore, the finishing nail will be held toward the base of the tube with firm pressure of the tube on the patient's skin to ensure consistent pressure is provided. For both groups, the patient will be prone so that the patient remains blinded to the treatment. All set up procedures will take place after the patient has assumed the prone positon. After the patient has assumed the prone position, the treating physical therapist will prepare the treatment area as previously described. All materials associated with the intervention will be discarded and removed from the treatment area before the patient comes out of the prone position. The duration of the total treatment program will be determined by the treating physical therapist based on the impairments and re-evaluation of the subjects status. Outcome measures will be collected at baseline. After one-month, or if the treating physical therapist deems the subject is appropriate for discharge (whichever comes first), all outcome measures will be reassessed. If the subject should need additional physical therapy after the one-month period, the physical therapist will document the types of interventions provided, and any additional healthcare utilization variables, including physical therapy utilization, and a final collection of outcomes. Follow up will be conducted at one-week, one-month (or discharge, whichever comes first) months and at 6 months to collect outcomes data.
Experimental: Dry needling and exercise
Sham Comparator: Sham dry needling and exercise
Other: - Dry needling
Trigger point dry needling to trigger points in the shoulder or parascapular muscles using monofilament needle (i.e., acupuncture needle). Clean needle approach using sterile needles.
Other: - Sham Dry Needling
Sham needle approach using a finishing nail in a tube sheath. The finishing nail will be placed over the trigger point so that the patient perceives a sharp sensation. The tube (not the nail) will be moved up and down to mimic the action of needling.
Other: - Therapeutic Exercise
Exercise including flexibility, range of motion, strengthening will be provided by the treating physical therapist based on the impairments identified.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Duke Sports Science Institute
Durham, North Carolina, 27710