- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07672028
ERGON Therapy and Muscle Energy Technique for Mechanical Neck Pain (ERGOMET)
Comparison of ERGON Therapy With and Without Muscle Energy Technique in Patients With Mechanical Neck Pain: A Randomized Clinical Trial
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Mechanical neck pain is a common musculoskeletal condition that can adversely affect daily activities, work productivity, and quality of life. Various manual therapy approaches have been used to manage neck pain, including Instrument-Assisted Soft Tissue Mobilization (IASTM) techniques such as ERGON Therapy and Muscle Energy Technique (MET). However, limited evidence exists regarding the comparative effectiveness of ERGON Therapy with and without MET in individuals with mechanical neck pain.
This randomized clinical trial will recruit 42 participants diagnosed with mechanical neck pain. Eligible participants will be randomly allocated into two groups. Group A will receive ERGON Therapy in combination with Muscle Energy Technique, while Group B will receive ERGON Therapy alone. In addition, both groups will receive a standardized conventional physiotherapy program consisting of TENS, hot pack application, and cervical stretching exercises.
The intervention period will be conducted according to a predefined treatment protocol. Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), cervical range of motion measured using appropriate clinical tools, and functional disability assessed using the Neck Disability Index (NDI). Assessments will be performed at baseline and after completion of the intervention period.
The primary objective of the study will be to determine whether the addition of Muscle Energy Technique to ERGON Therapy provides superior improvements in pain reduction, cervical mobility, and functional disability compared with ERGON Therapy alone. The results of this trial are expected to contribute to evidence-based rehabilitation strategies for the management of mechanical neck pain.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Sialkot, Pakistan, 54910
- Bethania Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
Individuals clinically diagnosed with mechanical neck pain Duration of neck pain of at least 2 weeks Willingness to participate and provide written informed consent
Exclusion Criteria:
History of cervical spine surgery within the past 12 months History of trauma or infection in the cervical region Presence of neurological deficits or cervical radiculopathy Presence of systemic disorders affecting musculoskeletal function Any other musculoskeletal deformity or significant disability affecting the neck region
-
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental Group
ERGON Therapy combined with Muscle Energy Technique plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
|
Participants in the experimental group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique combined with Muscle Energy Technique.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
Muscle Energy Technique will be used to facilitate joint mobility and reduce muscular tightness.
In addition, participants will receive conventional physiotherapy including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
Andere namen:
|
|
Actieve vergelijker: Comparator Group
ERGON Therapy alone plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
|
Participants in the comparator group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique alone.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
In addition, participants will receive the same conventional physiotherapy protocol including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Intensity (NPRS)
Tijdsspanne: Baseline and after completion of 6 treatment sessions (2 weeks)
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
|
Baseline and after completion of 6 treatment sessions (2 weeks)
|
|
Cervical Range of Motion (CROM)
Tijdsspanne: Baseline and after completion of 6 treatment sessions over 2 weeks
|
Cervical range of motion refers to the measurement of movement of the cervical spine in different planes, including flexion, extension, lateral flexion, and rotation.
It reflects neck mobility and functional joint movement and will be assessed using standard clinical methods at baseline and post-intervention.
|
Baseline and after completion of 6 treatment sessions over 2 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Functional Disability (Neck Disability Index - NDI)
Tijdsspanne: Baseline and after completion of 6 treatment sessions over 2 weeks
|
Functional disability related to mechanical neck pain will be assessed using the Neck Disability Index (NDI).
The questionnaire measures the impact of neck pain on activities of daily living, including personal care, lifting, reading, work, and concentration.
Higher scores indicate greater disability.
|
Baseline and after completion of 6 treatment sessions over 2 weeks
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: DANYAL AHMAD, University of Management and Technology Sialkot Pakistan
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- kuhs/dpt/umt-skt-028
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personally identifiable information such as names, contact numbers, or hospital identification numbers will be included.
Supporting study documents such as study protocol and data collection forms may also be made available.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .