NCT04696341

Brief Summary

Thirty individuals with chronic neck pain randomised into two groups. Group I (15 subjects) received a total of 10 sessions as 5 sessions a week.Hot pack to cervical and upper thoracic regions (20 minutes), conventional Transcutaneous Electrical Nerve Stimulation (TENS) (100 Hz for 40 μsec), therapeutic ultrasound (1 Megahertz (MHz) for 5 minutes) and conventional massage were applied. Five sessions of Matrix Rhythm Therapy (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy Group II. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 minutes. Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm. Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm. Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. Turkish version of Beck Depression Inventory was used to assess emotional status of participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable chronic-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2011

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

14 days

First QC Date

January 1, 2021

Last Update Submit

January 5, 2021

Conditions

Keywords

Matrix Rhythm TherapyMassagePhysical TherapyNeck Pain

Outcome Measures

Primary Outcomes (4)

  • Pain intensity

    Pain intensity was measured using by a Visual Analogue Scale (VAS) measuring 10 cm (0: I have no pain, 10: I have an intolerable pain). Higher scores mean a worse outcome.

    Baseline

  • Muscle spasm

    Muscle spasm in cervical region was assessed by using a VAS measuring 10 cm (0: no spasm, 10: the most severe spasm). Higher scores mean a worse outcome.

    Baseline

  • Disability

    Turkish version of Neck Disability Index (NDI) was used to assess the disability caused by neck pain. NDI is composed of a total of 10 questions of which 4 about subjective symptoms Each section is scored between 0 and 5. For total scores 0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability

    Baseline

  • Emotional status

    Turkish version of Beck Depression Inventory was used to assess emotional status of participants. Each question of the questionnaire which is composed of 21 questions is scored between 0 and 3. Higher scores than 17 mean risc for depression.

    Baseline

Secondary Outcomes (4)

  • Pain intensity

    2 weeks

  • Muscle spasm

    2 weeks

  • Disability

    2 weeks

  • Emotional status

    2 weeks

Study Arms (2)

Matrix Rhythm Therapy

EXPERIMENTAL

Group I (15 subjects) received 10 sessions as 5 sessions a week. Hot pack to cervical and upper thoracic regions, conventional TENS, therapeutic ultrasound, conventional massage and Matrix Rhythm Therapy were applied. Home-based exercise program and recommendations were also given to patients.

Procedure: Matrix Rhythm Therapy

Control

EXPERIMENTAL

Group II (15 subjects) received 10 sessions as 5 sessions a week. Hot pack to cervical and upper thoracic regions, conventional TENS, therapeutic ultrasound and conventional massage were applied. Home-based exercise program and recommendations were also given to patients.

Procedure: Control

Interventions

Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 μsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.Five sessions of MRT (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy to Matrix Rhythm Group. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 min (15 min for right and left sides each) according to the instructions of the technique developer.

Matrix Rhythm Therapy
ControlPROCEDURE

Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 μsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having neck pain for at least 3 months

You may not qualify if:

  • radiculopathy with motor findings
  • undergoing surgical operation for neck pathologies
  • having a systemic , neurologic, psychiatric diseases
  • inflammatory or infectious diseases targeting this region
  • physical therapy modalities could not be used due to contraindications (individuals with sensory disorders, who use cardiac pace maker)
  • pregnancy
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarayköy Vocational School

Denizli, 20300, Turkey (Türkiye)

Location

Related Publications (3)

  • Taspinar F, Aslan UB, Sabir N, Cavlak U. Implementation of matrix rhythm therapy and conventional massage in young females and comparison of their acute effects on circulation. J Altern Complement Med. 2013 Oct;19(10):826-32. doi: 10.1089/acm.2012.0932. Epub 2013 Apr 26.

  • Smidt N, de Vet HC, Bouter LM, Dekker J, Arendzen JH, de Bie RA, Bierma-Zeinstra SM, Helders PJ, Keus SH, Kwakkel G, Lenssen T, Oostendorp RA, Ostelo RW, Reijman M, Terwee CB, Theunissen C, Thomas S, van Baar ME, van 't Hul A, van Peppen RP, Verhagen A, van der Windt DA; Exercise Therapy Group. Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. Aust J Physiother. 2005;51(2):71-85. doi: 10.1016/s0004-9514(05)70036-2.

  • Ylinen J. Physical exercises and functional rehabilitation for the management of chronic neck pain. Eura Medicophys. 2007 Mar;43(1):119-32.

MeSH Terms

Conditions

Chronic PainNeck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emine ASLAN TELCİ, Professor

    Pamukkale University

    STUDY CHAIR
  • Erhan ÖZFİDAN, Dr

    Private Denizli Tekden Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
All assessments were done by the same physiotherapist (FU) before therapy and at the end of treatment sessions. The physiotherapist who did the assessments did not know to which group the subjects were belonged. Another physiotherapist who was not informed about the results of the evaluation treated the patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturar

Study Record Dates

First Submitted

January 1, 2021

First Posted

January 6, 2021

Study Start

March 25, 2011

Primary Completion

April 8, 2011

Study Completion

May 6, 2011

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Because there is no web site to share my data

Locations