None listed
Conditions
Brief summary
The purpose of the study is to determine the best shock wave therapy protocol for a widely used treatment for calcific soft tissue conditions in musculoskeletal medicine. We would like to see whether the addition of ultrasound to shock wave therapy in treatment of calcific soft tissue pathologies improves patient outcome as determined by decrease in pain, improvement of function and decrease in size of the calcification. We believe that treatment outcome may be similar between groups. However it is possible that for superficial conditions patient guided protocols may be slightly superior. In deep structures such as the shoulder tendon the addition of ultrasound to target the exact area of calcification may be slightly superior . This study will hopefully help answer these questions.
Interventions
All patients will receive active treatment i.e. shockwave therapy, with the SHOCK WAVE THERAPY PROTOCOL described as below:
1. NUMBER & FREQUENCY OF TREATMENT SESSIONS:
3-5 treatment sessions.
Treatment sessions will be spaced at 1 week intervals.
(NB.Number of sessions of treatment are based on patient's response to treatment. All patients will receive 3 treatment sessions. Patients who feel they have not had a decrease in their pain or improvement in function can have an additional 2 tr
All patients will receive active treatment i.e. shockwave therapy, with the SHOCK WAVE THERAPY PROTOCOL described as below: 1. NUMBER & FREQUENCY OF TREATMENT SESSIONS: 3-5 treatment sessions. Treatment sessions will be spaced at 1 week intervals. (NB.Number of sessions of treatment are based on patient's response to treatment. All patients will receive 3 treatment sessions. Patients who feel they have not had a decrease in their pain or improvement in function can have an additional 2 treatment sessions). 2. DURATION OF TREATMENT SESSIONS: Each treatment session will take between 20-30mins depending on the arm of the study. Arm 1 (patient-guided shockwave treatment) will take about 20 mins. Arm 2 ( ultrasound-guided shockwave treatment) will take about 30 mins with the additional 10 mins needed to locate the calcification on ultrasound prior to treatment. All session times also include filling out questionnaire prior to treatment, setting up the patient for treatment and arranging the follow up appointment or answering any questions. The shockwave treatment itself takes less than 5 mins. 3.SHOCKWAVE MACHINE SETTINGS: 2000 Impulses, 20 Hz , over a range of 1.4-2 bar. 4. THE TWO STUDY ARMS OF PARTICIPANTS: Arm 1: Patient-guided shock wave therapy to the area where the most pain is felt in relation to the area of calcification. Arm 2: Ultrasound-guided shock wave therapy to the exact site of calcification.
Sponsors
Dr John Orchard
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pain in one of 3 areas - either shoulder rotator cuff tendon, achilles tendon or plantar fascia; Proven calcification visible on previous imaging;Calcification visible on our ( the investigator's) ultrasound machine; Males and non-pregnant females; fluent in english; able to give informed consent; seeking to try shockwave treatment as a method to resolve the pain; willing and able to follow the research protocol
Exclusion criteria
Calcification unable to be seen on our ( the investigator's) ultrasound machine; unable to follow the protocol; unable to tolerate the shock wave treatment according to the protocol because it is too painful; corticosteriod injection to the area inthe last 3 months ( as this may affect treatment efficacy); pregnancy or suspected pregnancy during the study; cancer; local lesions or non-intact skin; osteoarthritis at treatment site; Polyneuropathy; bleeding or clotting conditions; anticoagulation medications; allergy to ultrasound gel.
Outcome results
None listed