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This randomised, controlled, double-blind experimental study is designed to evaluate the efficacy of a standardised manual physiotherapy protocol for treating lateral epicondylalgia of the humerus, commonly known as 'tennis elbow'. The study will compare the results for patients receiving active treatment with those for a control group who will follow a watchful waiting approach. Secondary objectives include analysing the relationship between pain, grip strength and joint mobility in the elbow and cervical spine. A sample of healthy subjects will also be included to establish baseline data and measure the effects of the protocol in an asymptomatic population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Therapy Protocol | Experimental | Manual techniques will be performed on the cervical and dorsal areas and on the elbow. High-speed techniques combined with stretching techniques, myofascial relaxation and neural mobilisation. |
|
| Sham Manual Protocol | Sham Comparator | Mobilisation techniques will be performed without reaching the final joint movement parameters in the same areas where manual contact is applied in the intervention group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy | Other | Manual techniques will be performed on the cervical and dorsal areas and the elbow, as well as on the soft tissues associated with these areas. High-speed techniques, stretching techniques, myofascial relaxation techniques and neural mobilisation techniques will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Perceived Pain | Perceived pain intensity will be assessed during palpation, positive inclusion-criteria tests, and activities of daily living using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the maximum perceived pain" | Baseline, 6 weeks, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) of the Elbow and Cervical Spine | Assessment of elbow mobility (flexion, extension, pronation, and supination) and cervical spine mobility (flexion, extension, lateral flexion, and rotation) using goniometers and inclinometers. Results are reported in degrees (°), where higher values indicate greater mobility and improvement. | Baseline, 6 weeks, 3 months, 6 months, 12 months |
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Inclusion Criteria:
Subjects must meet a minimum of 4 of the 5 inclusion criteria to be part of the study. In addition to the inclusion criteria, subjects must be between 18 and 60 years of age, able to answer questionnaires in Spanish, and give their written consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Ciencias de la Salud | San Cristóbal de La Laguna | Santa Cruz de Tenerife | 38200 | 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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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Sham Manual Therapy | Other | Mobilisation techniques will be performed without reaching the final parameters of joint movement in the same areas where manual contact is applied in the intervention group. |
|
| Grip Strength | Measurement of the strength of the wrist and hand flexors and extensors using a hand-held pressure dynamometer. Results are reported in kilograms (kg). Higher values indicate greater muscle strength. | Baseline, 6 weeks, 3 months, 6 months, 12 months |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |