Assessment of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) After Effect in Patients With and Without Tennis Elbow (TE)

NCT ID: NCT07178288

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2025-12-30

Brief Summary

This study at Hashemite University looks at how people with and without tennis elbow (AKA lateral elbow tendinopathy) feel pressure pain and how their bodies briefly "turn down" pain after a cold stimulus. Participants complete brief questionnaires (basic demographics without names, a tennis-elbow symptom form, and a physical-activity form) and then have their pressure-pain threshold (PPT) tested with a handheld device that slowly increases pressure on standard spots near the elbow and wrist; they say when it first becomes painful. To test the body's built-in anti-pain system (conditioned pain modulation, CPM), one hand is placed in ice water (the cold-pressor task) and PPT is measured again at set times (before, during, and after the cold stimulus) to see how much pain sensitivity changes and how long that change lasts. Both PPT reliability and CPM after effect are measured in this study. The study findings may help improve future assessment and treatment of musculoskeletal pain conditions.

Detailed Description

This is a quasi-experimental reliability and time-course study using digital algometry for PPT and the cold-pressor task for CPM. Primary outcomes include PPT reliability (with intraclass correlation coefficient (ICC), standard error of measurement (SEM), and smallest detectable change (SDC) and the duration of CPM after-effects (time to return toward baseline). Testing is planned in the Physiotherapy Clinic at the Community Rehabilitation Center, with a minimum sample noted in the application. The protocol emphasizes standardized sites, repeated measures at predefined time points, and storage of coded data on university systems.

Conditions

Tennis Elbow; Health Adult Subjects; Lateral Elbow Tendinopathy (Tennis Elbow); Pressure Pain Threshold (PPT); Conditioned Pain Modulation (CPM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PPT_CPM Arm

Procedure After completing self reported questionnaires, participants will attend a single test session where they undergo a Pressure Pain Threshold (PPT) test-retest protocol followed by a Conditioned Pain Modulation (CPM) testing protocol, with a rest period of 10 minutes in between. The experimental protocols will be performed by the same investigator. All instructions will be standardized

Group Type: EXPERIMENTAL

Physiological/measurement-validation study

Intervention Type: OTHER

Protocols PPT Reliability The assessor measured Pressure Pain Threshold; PPT, using an electronic digital algometer. Measurements will be taken at two test sites wrist at baseline, at 1, 3 and 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis.

Conditioned Pain Modulation In order to assess CPM, PPT was used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs will assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) will be used as the conditioning stimulus. Participants will be instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT will be measured at baseline pre and 1 minute during immersion to calculate CPM response, and then at various time points post immersion (minutes: 1, 5, 15, 30, 45, and 60) to determine the time point at which PPT returns to baseline.

Interventions

Physiological/measurement-validation study

Protocols PPT Reliability The assessor measured Pressure Pain Threshold; PPT, using an electronic digital algometer. Measurements will be taken at two test sites wrist at baseline, at 1, 3 and 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis.

Conditioned Pain Modulation In order to assess CPM, PPT was used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs will assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) will be used as the conditioning stimulus. Participants will be instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT will be measured at baseline pre and 1 minute during immersion to calculate CPM response, and then at various time points post immersion (minutes: 1, 5, 15, 30, 45, and 60) to determine the time point at which PPT returns to baseline.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients with Tennis Elbow confirmed at initial assessment by the Primary Investigator (PI)

Unilateral elbow pain > 6 weeks duration reproduced on at least two of the following tests:

• Palpation of the lateral epicondyle
• Isometric testing of the wrist extensors
• Middle finger extension test
• Passive stretch of wrist extensors
• Resisted hand gripping using a dynamometer
• Upper limb neurodynamic test-radial nerve bias (ULNDT-RN)

Exclusion Criteria

• History of chronic pain conditions (e.g. fibromyalgia, irritable bowel
• syndrome, temporomandibular dysfunction, migraines)
• Neurological or sensory dysfunction (especially in the upper limbs)
• History of chronic musculoskeletal pain (e.g. arthritis, chronic low back
• pain)
• Contraindications to cold application (i.e. Reynaud's disease, diabetes)
• Current or long-term use of pain medication or anti-depressants

Healthy Group The asymptomatic group included adults (18-65 years) without pain (acute or chronic) at least 3 months before the experimental sessions.

• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hashemite University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Muhsen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Muhsen

Role: PRINCIPAL_INVESTIGATOR

The Hashemite University

Locations

The Hashemite University, Department of Physical Therapy; Community Rehabilitation Center Clinics

Zarqa, Zarqa Governorate, Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Ahmad Muhsen, PhD

Role: CONTACT

muhsen_a@hu.edu.jo

+962788654656

References

Oono Y, Nie H, Matos RL, Wang K, Arendt-Nielsen L. The inter- and intra-individual variance in descending pain modulation evoked by different conditioning stimuli in healthy men. Scand J Pain. 2011 Oct 1;2(4):162-169. doi: 10.1016/j.sjpain.2011.05.006.

Reference Type: BACKGROUND

PMID: 29913755 (View on PubMed)

Bilika P, Kalamatas-Mavrikas P, Vasilis N, Strimpakos N, Kapreli E. Reliability of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in Participants with and without Chronic Shoulder Pain. Healthcare (Basel). 2024 Aug 31;12(17):1734. doi: 10.3390/healthcare12171734.

Reference Type: BACKGROUND

PMID: 39273758 (View on PubMed)

Other Identifiers

32/1/2024/2025

Identifier Type: -

Identifier Source: org_study_id