- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07724704
McGill Versus Sahrmann's Exercises for Chronic Non-Specific Low Back Pain
Effects of McGill Versus Sahrmann's Protocol on Pain, Range of Motion and Disability in Chronic Non- Specific Low Back Pain
The goal of this clinical trial is to compare the effects of McGill stabilization exercises and Sahrmann's movement-based exercise protocol in adults with chronic non-specific low back pain. The study aims to determine which exercise program is more effective in reducing pain, improving lumbar range of motion, and decreasing functional disability.
The main questions it aims to answer are:
Do McGill stabilization exercises reduce pain, improve lumbar range of motion, and decrease disability in individuals with chronic non-specific low back pain? Are McGill stabilization exercises more effective than Sahrmann's movement-based exercise protocol in improving pain, lumbar range of motion, and functional disability?
Researchers will compare the McGill stabilization exercise group with the Sahrmann exercise group to determine which intervention provides greater improvements in clinical outcomes.
Participants will:
Be randomly assigned to either the McGill stabilization exercise group or the Sahrmann exercise group.
Receive baseline physiotherapy, including hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), lumbar isometric exercises, pelvic tilts, knee-to-chest exercises, and manual therapy.
Attend supervised treatment sessions 2-3 times per week for 6 weeks. Complete outcome assessments before and after treatment using the Numeric Pain Rating Scale (NPRS) for pain, the Oswestry Disability Index (ODI) for disability, and a bubble inclinometer to measure lumbar range of motion.
This study will provide evidence on the comparative effectiveness of two commonly used physiotherapy exercise protocols and help identify the most effective rehabilitation approach for managing chronic non-specific low back pain.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Chronic non-specific low back pain (CNSLBP) is one of the leading causes of disability worldwide and is associated with persistent pain, reduced spinal mobility, impaired motor control, and limitations in daily activities. Unlike specific low back pain, CNSLBP has no identifiable pathological cause, making rehabilitation through exercise therapy the primary treatment approach. Current clinical guidelines recommend exercise-based interventions to improve pain, function, and quality of life; however, there is no consensus regarding the most effective exercise protocol for individuals with chronic non-specific low back pain.
Among the commonly prescribed physiotherapy interventions are the McGill stabilization exercise program and Sahrmann's movement-based exercise protocol. The McGill approach focuses on enhancing spinal stability by improving core muscle endurance and minimizing excessive spinal loading through spine-sparing stabilization exercises. In contrast, Sahrmann's protocol emphasizes correction of movement impairments, restoration of normal lumbopelvic movement patterns, and activation of deep stabilizing muscles to improve motor control and functional movement.
Although both rehabilitation approaches have demonstrated beneficial effects when studied individually, direct comparative evidence regarding their effectiveness in improving pain, lumbar range of motion, and functional disability remains limited. Existing studies have primarily evaluated each intervention separately or compared them with conventional physiotherapy rather than with each other. Consequently, clinicians have limited evidence to guide the selection of the most appropriate exercise protocol for patients with chronic non-specific low back pain.
This randomized controlled trial is designed to compare the clinical effectiveness of McGill stabilization exercises and Sahrmann's movement-based exercise protocol in adults with chronic non-specific low back pain. Clinical outcomes will be evaluated using validated measures of pain intensity, lumbar range of motion, and functional disability before and after the intervention period. The findings are expected to clarify whether one exercise approach provides superior improvements in patient outcomes and functional recovery.
The results of this study will contribute to evidence-based physiotherapy practice by providing comparative evidence on two widely used rehabilitation protocols. Identifying the more effective intervention may assist physiotherapists in selecting appropriate exercise programs, improving clinical decision-making, optimizing rehabilitation outcomes, and supporting the development of standardized conservative management strategies for individuals with chronic non-specific low back pain.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Imran Amjad, PhD
- Telefonnummer: 03324390125
- E-Mail: imran.amjad@riphah.edu.pk
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 60000
- Rekrutierung
- Lahore Clinic Shujabad, THQ Hospital Shujabad
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Kontakt:
- Annum Manzoor, MS-OMPT
- Telefonnummer: 03324880984
- E-Mail: drannummanzoor20@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria
- Adults aged 20-50 years.
- Male and female participants.
- Diagnosed with chronic non-specific low back pain lasting more than 12 weeks.
- Pain intensity of 3-4 on the Numeric Pain Rating Scale (NPRS) at baseline.
- Able and willing to participate in the exercise program and attend all treatment sessions.
- Willing to provide written informed consent.
Exclusion Criteria
- History of spinal surgery.
- Presence of neurological deficits.
- Structural spinal deformities.
- Pregnancy or within 6 months postpartum.
- Presence of red flag signs or systemic illness (e.g., fracture, infection, malignancy, inflammatory disorders).
- Individuals unable or unwilling to participate in the exercise program or complete the study protocol.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: McGill Stabilization Exercise Group
Participants in this group will receive the McGill stabilization exercise protocol in addition to baseline physiotherapy.
The exercise program is designed to improve core stability, spinal stability, lumbar range of motion, reduce pain, and improve functional ability in individuals with chronic non-specific low back pain.
The intervention will be administered according to the study protocol for 6 weeks.
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A progressive exercise program consisting of McGill stabilization exercises aimed at enhancing core muscle endurance, spinal stability, and neuromuscular control while reducing pain and improving lumbar function in individuals with chronic non-specific low back pain.
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Experimental: Sahrmann's Exercise Protocol Group
Participants in this group will receive the Sahrmann's movement-based exercise protocol in addition to baseline physiotherapy.
The program focuses on improving lumbopelvic control, correcting movement impairments, restoring normal movement patterns, reducing pain, increasing lumbar range of motion, and improving functional ability over a 6-week intervention period.
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A progressive movement-based exercise program designed to improve motor control, activate deep stabilizing muscles, correct faulty movement patterns, and enhance functional performance in individuals with chronic non-specific low back pain.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
1. Numeric Pain Rating Scale (NPRS)
Zeitfenster: [Time Frame: 6 Weeks]
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS).
The NPRS is a valid and reliable self-reported pain assessment tool that measures pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst imaginable pain").
Participants will be asked to select the number that best represents their current pain intensity.
A decrease in the NPRS score indicates an improvement in pain following the intervention.
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[Time Frame: 6 Weeks]
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2. Oswestry Disability Index (ODI)
Zeitfenster: [Time Frame: 6 Weeks]
|
Functional disability will be assessed using the Oswestry Disability Index (ODI).
The ODI is a disease-specific, validated questionnaire used to evaluate disability associated with chronic low back pain.
It consists of 10 sections covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling, and employment/homemaking.
Each section is scored from 0 to 5, with higher total scores indicating greater disability.
A reduction in the ODI score reflects improvement in functional status and daily activities.
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[Time Frame: 6 Weeks]
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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3. Bubble Inclinometer
Zeitfenster: [Time Frame: 6 Weeks]
|
Lumbar range of motion (ROM) will be measured using a bubble inclinometer, a reliable and valid instrument for assessing spinal mobility.
Measurements will be obtained for lumbar flexion, extension, right and left lateral flexion, and right and left rotation according to standardized measurement procedures.
The bubble inclinometer provides objective assessment of lumbar spinal movement in degrees.
An increase in lumbar range of motion indicates improvement following the intervention.
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[Time Frame: 6 Weeks]
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Annum Manzoor, MS OMPT, Gulab Devi Teaching institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Kernstabilisierungsübungen
- Schmerzintensität
- Funktionelle Behinderung
- Oswestry Disability Index (ODI)
- Chronische unspezifische Schmerzen im unteren Rückenbereich
- Numerische Schmerzbewertungsskala (NPRS)
- McGill Stabilization Exercise Protocol
- Sahrmann Exercise Protocol
- Lumbar Range of Motion
- Bubble Inclinometer
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REC/RCR & AHS/25/0146
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