The Effect of Manual Therapy on Central Sensitization

NCT05524870 | Completed

• 1 other identifier: 107/82
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases. Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases. Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.). Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways. However, there is no evidence of this mechanism available yet. Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.

Conditions

Subacromial Pain Syndrome; Central Sensitisation

Keywords

Manual therapy; Shoulder pain; Mobilization

Outcome Measures

Primary Outcomes (2)

• Central Sensitization Inventory

  The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization. The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100. Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization. A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization.

  Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.

• Pressure-Pain Threshold-Algometer

  Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain. A mechanical pressure algometer is used in this study to assess PPT. This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge. The gauge displays values in kilograms. Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter. The range of the algometer is 0 to 10 kg with 0.1-kg divisions. Higher scores indicate high PPT.

  Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.

Secondary Outcomes (1)

• Quick Disabilities of the Shoulder, Arm and Hand Questionnaire

  Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.

Study Arms (3)

Mobilization

EXPERIMENTAL

Mobilization with movement plus exercise.

Other: Mobilization

Sham mobilization

PLACEBO COMPARATOR

Sham mobilization with movement plus exercise

Other: Mobilization

Control

ACTIVE COMPARATOR

Exercise alone

Other: Mobilization

Interventions

Mobilization OTHER

Movement with mobilization plus exercise

Control; Mobilization; Sham mobilization

Eligibility Criteria

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

You may qualify if:

• To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests),
• To have \<40 score in central sensitization inventory.

You may not qualify if:

• To have bilateral subacromial pain,
• To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B)
• To have severe osteoarthritis or subluxation in shoulder joint,
• To have adhesive capsulitis,
• Being treated with physiotherapy for this disorder at least one month before the start of the study.
• To have severe cervical or lumbar radiculopathy,

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Director

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: February 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 5, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

TU (1)