NCT06498466

Brief Summary

Objectives: To investigate the effects of myofascial release therapy (MRT) on pain, number of trigger points (TP), pressure pain threshold (PPT), cervical range of motion (ROM), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (MPS). In this prospective study, patients in Group I (n=30) underwent a standard physical therapy program. Patients in Group II (n=30) additionally underwent MRT 3 days a week. Before and on the 15th day after treatment, patients' pain was measured by visual analog scale (VAS), TP numbers by palpation, PPTs by pressure algometer, cervical ROM by goniometer, disability by Neck Disability Index (NDI) and quality of life by Nottingham Health Profile (NHP) was evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 1, 2024

Last Update Submit

July 9, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Visual analog scale (VAS)

    The patients were asked to mark the severity of their neck pain at rest and with movement on a 10-centimeter (cm) line on the 1st and 15th days (0: minimum 10: maximum). The higher the measured value, the greater the pain intensity.

    2 weeks

  • Trigger Point Numbers

    In order to detect the trigger points, the neck and back regions of the patients were evaluated by palpation by the physician.

    2 weeks

  • Pressure Pain Threshold

    Pressure pain threshold (PPT) was measured with a pressure algometer (Commander\[JTECH medical\]). The disc head of the pressure algometer was placed on the trigger point at a 90° angle. Before the application, the patient was asked to describe the pain when he/she first felt it.

    2 weeks.

  • Cervical Joint Range of Motion (ROM)

    Cervical ROM measurements were evaluated actively and passively with a goniometer.

    2 weeks

  • Neck Disability Index

    Disability was evaluated with the Neck Disability Index. This questionnaire, which evaluates subjective symptoms and daily living activities, consists of a total of 10 sections (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep, and leisure activities).

    2 weeks

  • Nottingham Health Profile

    Quality of life was assessed with the Nottingham Health Profile. The scale consists of two parts. The first part consists of a total of 38 items, where each item is answered yes or no. This section has a total of 6 sub-dimensions: pain, emotional reactions, sleep, social isolation, physical activity, and energy. The second part consists of 7 items that question whether there are problems in business life, housework, social life, interpersonal relationships, sexual life, hobbies, and holidays, which are the areas of daily life that are most likely to be affected due to the person's health condition, and each item is answered yes or no.

    2 weeks

Interventions

Myofascial release therapy (MRT) is a manual therapy technique that involves gradual stretching by a therapist or the individual, acting on the muscles and surrounding fascia. Its effects include increasing joint range of motion and mobility of soft tissues, eliminating imbalances in muscle tone, reducing muscle pain, reducing stress on joints, and increasing neuromuscular efficiency.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome.

You may qualify if:

  • volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the Travell and Simons criteria for the diagnosis of Myofascial pain syndrome

You may not qualify if:

  • presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Facial Neuralgia

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Facial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 12, 2024

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations