Manual Therapy on Lateral Elbow Pain

March 6, 2026 updated by: Juan Elicio Hernández Xumet, University of La Laguna

Influence of 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38200
        • Facultad de Ciencias de la Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual Therapy Protocol
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.
Other: Manual Therapy
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 Comparator: Sham Manual Protocol
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.
Other: Sham Manual Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Baseline, 6 weeks, 3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 3 months, 6 months, 12 months
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.
Baseline, 6 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of La Laguna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI_53-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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