- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07720544
Instrument-assisted Soft Tissue Mobilization Versus Post - Isometric Relaxation Technique in Trapezius Myalgia. (IASTM)
17 juli 2026 uppdaterad av: Riphah International University
Effects of Instrument -Assisted Soft Tissue Mobilization Versus Post - Isometric Relaxation Technique on Pain,Range of Motion, and Function in Patients With Trapezius Myalgia.
effects of Instrument Assisted Soft Tissue Mobilization (IASTM) and Post-Isometric Relaxation (PIR) in reducing pain, improving range of motion, and enhancing function among individuals with trapezius myalgia.
it was a randomized clinical trial with outcome measuring tools as NPRS for pain Goniometer for ROM NDI for function
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A randomized clinical trial was carried out over ten months at Arif Memorial Teaching Hospital in Lahore.
The study included 48 participants aged between 25 and 35 years, selected through non-probability convenience sampling; 44 completed the full treatment.
Participants were randomly divided into two groups of 22 each using a lottery method.
Group A underwent IASTM combined with passive and self-stretching exercises, while Group B received the PIR technique.
Both interventions were administered three times weekly for six weeks.
Outcomes were assessed using the Numeric Pain Rating Scale (NPRS) for pain, a universal goniometer to measure cervical lateral flexion and rotation range of motion, and the Neck Disability Index (NDI) to evaluate functional limitations.
Evaluations were performed before treatment and again at the end of the six-week intervention.
Data analysis was conducted using SPSS-25, involving the Shapiro-Wilk test to assess normality, independent t-tests and Mann-Whitney U tests for intergroup comparisons, and paired t-tests along with Wilcoxon Signed Rank tests for intragroup analysis.
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Arif Memorial Teaching Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Individuals aged 25 to 35 experiencing trapezius myalgia,
- both men and women who report neck pain and stiffness,
- Limited range of motion in lateral neck bending and rotational movement.
- Presence of identifiable tender areas or trigger points within the trapezius muscle, Evidence of muscle tightness observed during mobility assessments, such as when performing lateral head tilt.
- A firm band of muscle tissue containing a hypersensitive point, often with a palpable nodule and potential for radiating discomfort.
Exclusion Criteria:
- Traumatic injury to the neck causing torticollis,
- Tumor affecting the upperportion of the trapezius muscle,
- Cervical nerverootirritation or damage, Break in one or more cervical vertebrae,
- Impairment of nervous system function,
- Swelling and hypersensitivity reactions in the skin,
- Abnormal spinal curvature and birth-related structural defects.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: GROUP 1 (Intrument assisted soft tissue mobilization)
IASTM (Members of this group received instrument-assisted soft tissue mobilization in addition to a standard intervention aimed at reducing pain and enhancing range of motion and functional ability.)
|
IASTM intervention was administered three times weekly for six weeks.
|
|
Aktiv komparator: GROUP 2(Post isometric relaxation)
Post isometric relaxation(The members of this group underwent post-isometric relaxation combined with the same standard protocol, with the same goals of alleviating pain and improving mobility and function.)
|
PIR intervention was administered three times weekly for six weeks.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numeric Pain Rating Scale
Tidsram: Baseline and after 6 weeks
|
The pain intensity was assessed using Numeric Pain Rating Scale (NPRS) an 11-point (0-10) tool used to measure a patient's pain intensity, where 0 means "no pain" and 10 means "the worst pain imaginable
|
Baseline and after 6 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Range of Motion
Tidsram: Baseline and after 6 weeks
|
ROM was measured using goniometer
|
Baseline and after 6 weeks
|
|
Neck Disability Index
Tidsram: baseline and after 6 weeks
|
The functions of neck was assessed using Neck Disability Index (NDI); The NDI is a 10-item patient-reported questionnaire designed to assess how neck pain affects daily activities such as personal care, lifting, reading, concentration, work, driving, sleeping, and recreation.
Each item is scored from 0 (no difficulty) to 5 (maximum difficulty), giving a total raw score ranging from 0 to 50.
The raw score is often converted to a percentage to standardize interpretation: NDI Percentage = (Total Score ÷ 50) × 100
|
baseline and after 6 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Saba Rafiq, PhD*, Riphah International University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2025
Primärt slutförande (Faktisk)
30 maj 2026
Avslutad studie (Faktisk)
30 juni 2026
Studieregistreringsdatum
Först inskickad
17 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- REC/RCR&AHS/25/0144
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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