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NCT Number: NCT07461311

Manual Therapy on Lateral Elbow Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Ciencias de la Salud

San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38200, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of epicondylalgia.
  • Pain on palpation of the epicondyle. Performed and measured with an algometer.
  • Pain on isometric contraction against resistance of the wrist extensors (epicondylar muscles).
  • Pain on contraction of the wrist and finger flexor muscles or pressure force. Performed and measured with a JAMAR manual pressure dynamometer.
  • Pain on stretching-elongation of the epicondylar muscles or Mills test (wrist and finger flexion, forearm pronation and elbow extension).
  • Pain during prono-supination movements of the forearm and/or flexion-extension of the elbow.

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

  • History of elbow fractures or cracks during the last twelve months.
  • History of elbow dislocations and/or subluxations during the last twelve months.
  • History of elbow surgery.
  • Congenital and/or acquired elbow deformity.
  • Organic elbow condition (osteoarthritis, arthritis).
  • Radio-humeral bursitis.
  • Radio-humeral chondromalacia.
  • Tear of the annular ligament.
  • Detachment of the periosteum.
  • Tendon rupture in the elbow.
  • Metabolic or infectious arthropathy.
  • Cervical pathology or cervicobrachial neuralgia.
  • Bilateral elbow pain.
  • Radial nerve compression neuropathy.
  • Participating in professional or amateur sports.
  • Having received treatment with injections, physiotherapy or manual physiotherapy for your condition during the previous 6 months.
  • Pain lasting less than 6 weeks.
  • Receiving other treatment during the study.
  • Patient absenteeism from treatment. We define patient absenteeism as missing a treatment session and/or measurement. We do not count delays of less than 2 days in a treatment session and/or measurement as absenteeism.

Treatment and study plan

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.

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.

Primary outcomes

  1. Intensity of Perceived Pain

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months

    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"

Secondary outcomes

  1. Range of Motion (ROM) of the Elbow and Cervical Spine

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months

    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.

  2. Grip Strength

    Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Registry information

Official study title

Influence of Manual Therapy on Lateral Elbow Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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