A Study Examining Changes in Pain After Manual Therapy in People With Achilles Tendon Pain

NCT06134856 | Completed

• 1 other identifier: PC02117
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to find out how pain sensation may change in the Achilles tendon after the use of manual physical therapy. The testing itself will use a device that gradually produces a sensation of heat or cold on your skin, which we will place directly over your Achilles Tendon. You will let the researcher know when the heat or cold becomes what you would describe as "slight discomfort," at which point the pressure will be stopped. Testing will be completed three (3) times in a row. The device has built-in programming which ensures that the heat or cold applied will be safe, even though it may be briefly uncomfortable. After this first testing the researchers will perform 1-3 repetitions of the ankle joint mobilization/manipulation. This technique involves the researcher providing a small quick stretching movement downwards at the ankle. This is a common therapeutic technique utilized by Physical Therapists, chiropractors, and physicians and is considered very safe. After this treatment we will perform the same measurements of hot and cold discomfort on your Achilles tendon

Conditions

Achilles Tendinopathy; Ankle Strain; Achilles Tendon Pain; Achilles Tendonitis

Keywords

Achilles; Tendinopathy; Tendonitis; Ankle; Pain

Outcome Measures

Primary Outcomes (1)

• Heat and Cold Thresholds

  Outcome variables will be mean scores for 3 trials each of heat and cold pain threshold, measured in degrees centigrade, initially and immediately (within 5 minutes) after the intervention or sham intervention, with analysis of threshold change measured in the post-test as compared to the baseline data.

  Baseline and 1 hour

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects assigned to the intervention group will then receive a talocrural joint high velocity, low amplitude thrush mobilization/manipulation. Standardized technique for this procedure involves the subject long-sitting with their back supported on the treatment table. The provider will then passively dorsiflex and evert the ankle to the point at which a joint tension end-feel is obtained. A small amplitude of movement is rapidly provided by the provider in a caudal direction. The provider may attempt up to three treatment thrust impulses, or until an audible cavitation is heard, indicating joint movement. Even without an audible cavitation, no more than three impulses will be provided. Some research in other body regions indicates that treatment effect is present even in those with whom audible joint cavitation is not noted.

Procedure: Ankle mobilization

Control

SHAM COMPARATOR

Subjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subjects ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change.

Procedure: Sham treatment

Interventions

Ankle mobilization PROCEDURE

Ankle joint mobilization as described in treatment arm description

Intervention

Sham treatment PROCEDURE

Light passive movement of the foot and ankle, avoiding the end-ranges which may actually elicit a mechanical change

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who self-report pain in the back of the heel (Achilles tendon) persisting for at least 3 months.

You may not qualify if:

• History of any surgery distal to the fibular head on the involved lower extremity
• Cortisone injection to the painful Achilles tendon within the last 6 months
• History of diagnosed ankle joint or connective tissue instability
• Current pregnancy
• Age under 18 years of age
• Unable or unwilling to give consent for test and/or treatment procedures

Sponsors & Collaborators

• Philadelphia College of Osteopathic Medicine: lead

Study Sites (1)

Philadelphia College of Osteopathic Medicine-GA

Suwanee, Georgia, 30024, United States

Location

MeSH Terms

Conditions

Tendinopathy; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott W Lowe

  PCOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects in the control group will receive 1 minute of passive ankle movement into ankle dorsiflexion. The researcher will not move the subject's ankle into a point where tissue stretch/tension is perceived. This will serve as an appropriate sham treatment since it still involves the subjects perception of treatment and includes the hands-on element of manual therapy, without the use of any tissue intervention which would theoretically effect change.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial, treatment group and control group

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: December 5, 2023
• Primary Completion: November 28, 2024
• Study Completion: March 5, 2025
• Last Updated: March 28, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)