Effect Of Shock Waves Therapy On Post Natal De Quarvain Tenosynovitis
This randomized controlled trial aims to investigate the effect of extracorporeal shock wave therapy (ESWT) on pain, wrist and thumb range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
De Quervain's tenosynovitis is a musculoskeletal condition affecting the abductor pollicis longus and extensor pollicis brevis tendons within the first dorsal compartment of the wrist. It is associated with pain, tenderness, restricted thumb and wrist movement, and difficulty performing daily activities. Postpartum women may be particularly affected because of repetitive wrist and thumb movements associated with infant care.
Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment modality being investigated for its potential effects on pain reduction and functional recovery in musculoskeletal disorders.
This study is designed as a prospective randomized controlled trial involving 40 postpartum women diagnosed with De Quervain's tenosynovitis. Participants will be randomly allocated into two equal groups of 20 women each.
The study group will receive extracorporeal shock wave therapy combined with a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises.
The control group will receive the same therapeutic exercise program without shock wave therapy.
Outcome assessments will be conducted before and after the treatment period. Pain intensity will be evaluated using the Visual Analogue Scale (VAS), wrist and thumb range of motion will be measured using a goniometer, and upper limb function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The study will compare changes within and between the two groups to evaluate the additional effect of shock wave therapy on pain, range of motion, and upper limb function in postpartum women with De Quervain's tenosynovitis.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mai Kamel Anwar, B.Sc
- Telefonnummer: 01001813906
- E-post: Maikamel905@gmail.com
Studera Kontakt Backup
- Namn: Elham Shahat Hassan, PhD
Studieorter
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Giza, Egypten
- Kasr El Ainy University Hospital
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Kontakt:
- Mai Kamel Anwar, B.Sc
- Telefonnummer: 01001813906
- E-post: Maikamel905@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Women in the postpartum period of > 6 months following labor
- Age: Between 25 and 35 years old.
- Body mass index: Between 25-30 kg / m2
- Diagnosis: Clinically diagnosed with De Quervain tenosynovitis by an orthopedic specialist or confirmed through clinical evaluation.
- Pain Severity: Presenting with moderate to severe pain (≥ 4 on the Visual Analogue Scale).
- Obstetric History: Multipara women (Cesarean section or normal labor)
- Stage of Condition Chronic stage: symptoms > 6 weeks
Exclusion Criteria:
- Previous Surgery: History of surgical intervention on the affected wrist or thumb.
- Skin Conditions: Open wounds, infections, or dermatological diseases at the application site that may interfere with shockwave therapy.
- Pregnancy: Pregnant or lactating women.
- Medication Use: Currently taking systemic corticosteroids, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) that may influence study outcomes.
- Pacemaker or Metal Implants: Presence of a cardiac pacemaker or metal implants near the treatment area.
- Other Physiotherapy: Receiving concurrent physiotherapy treatment for the same condition during the study period.
- Non-compliance: Inability or unwillingness to attend treatment sessions or follow instructions throughout the study duration.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Shock Wave Therapy + Therapeutic Exercises
Twenty postpartum women with De Quervain's tenosynovitis will receive extracorporeal shock wave therapy (ESWT) in addition to a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises. The exercise program will be performed for 30 minutes daily over four weeks. |
Extracorporeal shock wave therapy will be applied to the affected first dorsal compartment of the wrist using a radial shock wave device. Treatment parameters will include 1,000 impulses per session, with frequencies ranging from 18 to 21 Hz and pressure settings ranging from 1.4 to 1.8 bar, according to the study protocol.
Andra namn:
A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance. |
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Aktiv komparator: Therapeutic Exercises
Twenty postpartum women with De Quervain's tenosynovitis will receive a therapeutic exercise program consisting of tendon gliding, stretching, and strengthening exercises for 30 minutes daily over four weeks, without shock wave therapy. |
A structured therapeutic exercise program consisting of tendon gliding, stretching, active range-of-motion exercises, and progressive strengthening exercises targeting the wrist and thumb. Exercises will be performed for 30 minutes daily over four weeks, according to participants' tolerance. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain Intensity Measured by Visual Analogue Scale (VAS)
Tidsram: 4 weeks
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Pain intensity will be measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Lower scores indicate less pain. Changes in pain intensity will be compared between the study and control groups. |
4 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Wrist Flexion Range of Motion
Tidsram: 4 weeks
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Change in active wrist flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
|
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Wrist Extension Range of Motion
Tidsram: 4 weeks
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Change in active wrist extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Wrist Radial Deviation Range of Motion
Tidsram: 4 weeks
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Change in active wrist radial deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Wrist Ulnar Deviation Range of Motion
Tidsram: 4 weeks
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Change in active wrist ulnar deviation range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Flexion Range of Motion
Tidsram: 4 weeks
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Change in active thumb flexion range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Extension Range of Motion
Tidsram: 4 weeks
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Change in active thumb extension range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Abduction Range of Motion
Tidsram: 4 weeks
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Change in active thumb abduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Thumb Adduction Range of Motion
Tidsram: 4 weeks
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Change in active thumb adduction range of motion, measured in degrees using a universal goniometer. The change will be calculated as the post-treatment measurement minus the baseline measurement. |
4 weeks
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Upper Limb Disability Measured by DASH Questionnaire
Tidsram: 4 weeks
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Upper limb function and disability will be assessed using the 30-item Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The total score ranges from 0 (no disability) to 100 (maximum disability). Lower scores indicate better upper limb function. |
4 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Hala Mohamed Hanafy, PhD, Professor, Cairo University
- Studierektor: Sameh Hussien Samir, PhD, Professor, National Research Centre
- Studierektor: Elham Shahat Hassan, PhD, Ass. Professor, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P.T.REC/012/006319
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