self-myofascial release therapy and Achilles tendon complaints|
|- candidate number||27399|
|- NTR Number||NTR6576|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-jun-2017|
|- Secondary IDs||ID 6d1921 ToetsingOnline|
|- Public Title||self-myofascial release therapy and Achilles tendon complaints|
|- Scientific Title||Effectiveness of a 12-week self-myofascial release therapy on pain and tendon stiffness in active recreational runners with self-reported Achilles tendon complaints|
|- hypothesis||The purpose of this study will be to evaluate the effectiveness of a multifocal SMR treatment (directed to plantar aponeurosis, Achilles tendon and calf muscles) on pain and stiffness compared to ECC in active recreational runners with self-reported Achilles tendon complaints.|
|- Healt Condition(s) or Problem(s) studied||Achilles tendinopathy|
|- Inclusion criteria||Recreational runners aged 18 years or over, who have been running regularly for at least one year, suffering from self-reported Achilles tendon complaints (pain, stiffness and/or tenderness to touch). |
|- Exclusion criteria||Exclusion criteria are: (1) presence of severe cardiovascular, neurologic, endocrine, psychiatric, or orthopaedic diseases (except Achilles tendinopathy); (2) simultaneous participation in other studies; (3) pregnancy or nursing period; and (4) regular intake of analgesic drugs (5) symptoms to severe that they cause complete “inability to run”.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2017|
|- planned closingdate||31-dec-2017|
|- Target number of participants||74|
|- Interventions||Self-myofascial release exercises (intervention group)|
In the SMR group, the participants will use a foam roller and a foam ball to self-massage the plantar aponeurosis and the calf muscles twice a day for 90 seconds, respectively. The duration of each session will be, consequently, about three minutes, totalling approximately six minutes per day. The total treatment duration will be 12 weeks. In order to standardise the exerted pressure, a value of 6-7 for the on a numerical rating scale (NRS) ranging from 0 (no discomfort) to 10 (maximal discomfort) will be advised. Participants will be told that minor muscle soreness is to be expected during the first 5-10 days of training.
Eccentric exercises (control group)
In the ECC group, the participants will perform an eccentric loading program based on Alfredson et al. 1998. Two types of exercises will be used (Malliaras et at. 2013; Alfredson et al. 1998): (1) from an upright position and the body weight on the forefoot of both feet on a step, and with total plantar flexion of the ankle, the participants transfer all body weight to one lower limb, take off the contralateral foot from the step, and eccentrically allow the ankle to go to a total dorsiflexion position (maximum activation of the soles muscle); and (2) basically the same exercise, but now with the knee bent (maximum activation of the gastrocnemius muscle). Both eccentric exercises will be performed with three sets of 15 repetitions for each time, twice a day, for 12 weeks (Malliaras et at. 2013;
Alfredson et al. 1998). Different velocities of execution have shown not to influence treatment outcomes (Kellis et al. 1995). The participants will be instructed to allow pain at the same amount as the SMR group during the sets and to increase weight if the exercises can be performed without any minor pain or discomfort. Furthermore they will be told that minor muscle soreness is to be expected during the first 5-10 days of training.
|- Primary outcome||Primary outcomes|
The following primary outcomes will be assessed at baseline and post-treatment (12 weeks after baseline).
The VISA-A questionnaire (Victorian Institute of Sports Assessment – Achilles questionnaire) is aimed at assessing the severity of Achilles tendinopathy, and it consists of eight questions covering different domains: pain; self-reported tendon stiffness; function; and activity (Robinson et al. 2001). A total score ranging from 0 to 100 is calculated based on the responses of the eight questions. Questions 1 to 7 are scored based on response alternatives varying from 0 to 10. Question 8 is scored based on response alternatives varying from 0 to 30. The VISA-A questionnaire has demonstrated good to excellent test-retest, intra-rater, and inter-rater reliability as well as sufficient construct validity (Robinson et al. 2001). A validated dutch version of the questionnaire will be used (van Sterkenburg, M.N. 2012).
Mechanical pain threshold
A handheld mechanical algometer (diameter of 1 cm², pdt, USA) will be used to determine the mechanical pain threshold (MPS), which represents a surrogate of the pressure sensitivity. The anatomical location of this measure will be on the Achilles tendon at the height of the lateral malleolus. Using the tip of the algometer, an investigator will apply an increasing pressure to the tendon at a rate of approximately 1 kg/cm²/s until the subject reports a painful sensation. The corresponding force value (kg/cm²) will be recorded. The lower the score (and thus mechanical pain threshold) the higher is the tenderness of the tissue in the tested area. Three measurements with 10-second time intervals will be performed. The second and the third measurement are employed for further analysis. Sufficient repeated-measures reliability of the procedure has been demonstrated by Nussbaum and Downes (1998).
Self-perceived clinical progress
Clinical progress will be assessed with an 11-point (-5 to +5) Global Rating of Change scale (GROC) (Kamper et al. 2009) with written descriptors at the ends (negative for deterioration, positive for improvement) and the midpoint (no change). To evaluate changes in symptoms and their influence in activities, the VISA-A questionnaire will be used.
|- Secondary outcome||A web-based log will be developed in order to collect data on: (1) running exposure (hours/week, km/week, and times/week); (2) level of pain during running assessed with an 11-point NRS (0 to 10); (3) VISA-A-score; (4) self perceived clinical process (GROC); (5) adherence to the assigned treatment (SMR or ECC); and (6) competing interventions (performance of other interventions alongside with the assigned treatment including medication). |
Data on these secondary outcomes will be collected every other week throughout the study (12 weeks).
|- Timepoints||Week 1-3 - Recruitment and inclusion of subjects|
Week 4-5 - Baseline measurements
Weeks 4-17 - Follow-up
Week 16-17 - Follow-up measurements
Week 18-20 - Data analysis
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Evert Verhagen|
|- CONTACT for SCIENTIFIC QUERIES|| Evert Verhagen|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Pain and stiffness of the Achilles tendon are a common running-related injury (RRI). One of the standard exercises in treating the complaints are eccentric exercises (ECC). It requires muscle activation thus focusing on the calf muscles. Anatomically, the Achilles tendon not only fuses with the calf muscles but has a fibrous connection with the plantar foot, the aponeurosis plantaris. Targeting not only the calf muscles but also the aponeurosis, sely-myofascial release (SMR) represents a good option for multifocal treatment. SMR has become more popular the last years. It is thought to it stimulate collagen I production and reverse pathological neovascularization. Moreover, although evidence is scarce so far, SMR has been described to loosen fascial adhesions and cross-links, increase the gliding capacities of connective tissue layers, decrease muscle tension and to alter mechanical stiffness. SMR does not impede athletic performance. It has also been suggested that SMR might have, as all manual therapies, a potentially pain-relieving effect. These analgesic effects may be mediated by either peripheral, spinal or supra-spinal mechanisms. All of the above mentioned processes might help to restore physiological tendon function.
The purpose of this study will be to evaluate the effectiveness of a multifocal SMR treatment (directed to plantar aponeurosis, Achilles tendon and calf muscles) on pain and stiffness compared to ECC in active recreational runners with self-reported Achilles tendon complaints.
Is a 12-week multifocal SMR treatment more effective in treating Achilles tendon complaints than ECC in active recreational runners?
Single blinded, randomized pilot study using a 2 group design with a treatment period of 12 weeks.
Active recreational runners older than 18 years with self-reported Achilles complaints.
|- Main changes (audit trail)|
|- RECORD||15-jun-2017 - 5-aug-2017|
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