Chronic midportion Achilles tendinopathy Mental and Behavioural Disorders Achilles tendinitis
Conditions
Interventions
Current interventions as of 30/10/2012:
IMS treatment group
Intramuscular Stimulation (IMS) involves the insertion of fine sterile needles into tender and painful point
Sponsors
University of British Columbia (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/10/2012: 1. Aged 19 to 60 years of age with a 3-month minimum symptom duration 2. Evidence of midportion Achilles tendinopathy by history and on physical examination 3. Objective signs by Gunn IMS assessment of neuropathic change in the L5-S2 segmental levels including the presence of taut muscle bands amenable to IMS. Tight bands palpated in muscles paraspinally (dorsal rami) from T1 down and peripherally (ventral rami) from T12 down will also be treated in the IMS group participants Previous inclusion criteria until 30/10/2012: 2. Evidence of midportion Achilles tendinopathy on physical examination and tendinosis on ultrasound
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/09/2014: 1. IMS contraindications: 1.1. Infection in the area 1.2. Pregnancy 1.3. Bleeding disorders 1.4. History of bacterial endocarditis 1.5. Post-surgical implant in last 4-6 months and major surgery in the last 3 months 2. Previous treatment with IMS or TCMA (for blinding purposes) 3. True leg length difference of greater than half and inch 4. Previous corticosteroid injections or recent fluoroquinolone use and systemic inflammatory disease. 5. Those demonstrating the presence of other syndromes that cause pain in and around the Achilles, e.g.: 5.1. Partial tearing 5.2. Posterior ankle impingement/os trigonum syndrome 5.3. Dislocation of the peroneal or other plantar flexor tendons 5.4. Irritation or neuroma of the sural nerve or insertional Achilles pain Exclusion criteria from 30/10/2012 to 15/09/2014: 1. IMS contraindications: 1.1. Infection in the area 1.2. Pregnancy 1.3. Bleeding disorders 1.4. History of bacterial endocarditis 1.5. Post-surgical implant in last 4-6 months and major surgery in the last 3 months 2. Previous treatment with IMS or TCMA (for blinding purposes) 3. True leg length difference of greater than half and inch 4. Previous corticosteroid injections or recent fluoroquinolone use and systemic inflammatory disease. 5. Those demonstrating the presence of other syndromes that cause pain in and around the Achilles, e.g.: 5.1. Partial tearing 5.2. Posterior ankle impingement/os trigonum syndrome 5.3. Tenosynovitis 5.4. Dislocation of the peroneal or other plantar flexor tendons 5.5. Irritation or neuroma of the sural nerve or insertional Achilles pain Original exclusion criteria until 30/10/2012: 5. Those demonstrating the presence of other syndromes that cause pain in and around the Achilles, e.g.: 5.1. Partial tearing 5.2. Posterior ankle impingement/os trigonum syndrome 5.3. Tenosynovitis 5.4. Dislocation of the peroneal or other plantar flexor tendons 5.5. An accessory soleus muscle 5.6. Irritation or neuroma of the sural nerve or insertional Achilles pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 11/04/2013: The primary outcome measure for which the study is powered is the 12-week VISA-A score - a well-validated and reliable disease-specific outcome measure, which also includes an activity-related pain scale. Secondary outcome measures include treatment success/failure, and muscle length (dorsiflexion ROM). Patients will rate themselves from 0 (very much worse) to 6 (very much improved). Scores of very much improved or much improved will be categorized as successes. Dorsiflexion range of motion with knee bent and straight will also be measured, giving an indication of the effect of IMS and exercise vs exercise alone on muscle extensibility. These measures will be taken at 0 weeks, 12 weeks, 6 months, and 52 weeks. At 12 weeks a follow-up UTC scan will be conducted to determine, as a pilot study, whether there is any subjective indication of a potential effect of IMS on tissue remodeling that could be pursued with a mechanistic study in future. Muscle length measures will be made according to the protocol described by Norkin and White and Kendall and colleagues by a paid, experienced physiotherapist unaware of the treatment allocation. The two-joint plantarflexors (gastrocnemius and plantaris) will be measured in supine with the knee extended. The one-joint plantarflexors will also be measured in supine but with the hip and knee flexed 90 degrees or more to make the two-joint plantar flexors slack across the knee joint. The ankle will be passively dorsiflexed and the angle achieved measured by inclinometry. The fulcrum will be centred over the lateral aspect of the lateral malleolus, the proximal arm will be aligned with the lateral midline of the fibula, using the head of the fibula for reference, and the distal arm will be positioned parallel to the lateral aspect of the fifth metatarsal. The ankle will be dorsiflexed to end-of-range (firm muscular end-feel) by pushing upward across the | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global improvement scale 2. Dorsiflexion range of motion | — |
Countries
Canada
Outcome results
None listed