Manual Therapy on Lateral Elbow Pain

NCT07461311 | Active Not Recruiting

• 1 other identifier: PI_53-14
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tennis Elbow

Keywords

physical therapy; manual therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Range of Motion (ROM) of the Elbow and Cervical Spine

  Baseline, 6 weeks, 3 months, 6 months, 12 months

• Grip Strength

  Baseline, 6 weeks, 3 months, 6 months, 12 months

Study Arms (2)

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.

Other: Manual Therapy

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.

Other: Sham Manual Therapy

Interventions

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.

Manual Therapy Protocol

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.

Sham Manual Protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of La Laguna: lead

Study Sites (1)

Facultad de Ciencias de la Salud

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

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Clinical Professor; Head of the Clinical Research Laboratory - Physiotherapy Department

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: March 10, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

ES (1)