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Diacutaneous Fibrolysis (DF) is a manual method of treatment, usually adjuvant, addressed to the mechanical pain of the locomotor system. In our clinical practice a favorable effect is observed in patients with chronic lateral epicondylitis, but there are no published studies evaluating the results of this technique.
The objective of this trial is to evaluate if DF provides a further improvement in pain intensity, pain-pressure threshold, function and pain-free grip strength, in patients with chronic lateral epicondylitis being treated with physiotherapy. For this purpose, we conduct a randomized controlled trial, double-blind (patient and evaluator) in a Public Primary Care Center.
Sixty subjects will be randomized (computer application) into three groups: Intervention Group, Placebo Group and Control Group. All the three groups receive the same protocolized treatment of physiotherapy and additionally. Additionally, the Intervention Group receives six sessions (two sessions in a week during three weeks) of real DF and the Placebo Group receives six sessions (two sessions in a week during three weeks) of sham DF. The Control Group receives the protocolized treatment of physiotherapy only.
Pain intensity (VAS), pain-pressure threshold (pressure algometry), function (DASH questionnaire) and pain-free grip strength (digital dynamometer) will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through the Global Rating of Change (GROC) scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Actual Diacutaneous Fibrolysis and Protocolized Physiotherapy |
|
| Placebo Group | Sham Comparator | Sham Diacutaneous Fibrolysis and Protocolized Physiotherapy |
|
| Control Group | Other | Protocolized Physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actual Diacutaneous Fibrolysis | Other | Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. The hook is deeply applied following the intermuscular septum between the muscles with an anatomical of functional relationship with the painful structure in order to release adherences between musculoskeletal structures. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity (VAS) | pre-intervention, post-intervention (two sessions in a week during three weeks), after three months |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Pain Threshold | pressure algometry | pre-intervention, post-intervention (two sessions in a week during three weeks), after three months |
| Pain free grip strength | digital dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalan Institut of Health - Sant Ildefons Rehabilitation Center | Recruiting | Cornellà de Llobregat | Barcelona | 08940 | Spain |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Sham Diacutaneous Fibrolysis | Other | Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels. |
|
| Protocolized Physiotherapy | Other | Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy |
|
| pre-intervention, post-intervention (two sessions in a week during three weeks), after three months |
| Functional status | DASH questionnaire | pre-intervention, post-intervention (two sessions in a week during three weeks), after three months |
| Global Rating of Change scale | post-intervention, after three months |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |