- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07641972
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.
10. Juni 2026 aktualisiert von: Riphah International University
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction on Pain, Lumbar Mobility and Functional Disability in Patients With Lumbar Spine Radiculopathy.
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria.
Eligible participants will be asked for their informed consent.
Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent.
Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test.
After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction.
Every participant will get treatment for four weeks, with three sessions per week.
At the conclusion of the intervention period, a post-intervention assessment will be carried out.
Randomization: Random allocation of participants into the two groups, Group A and Group B, will be performed by a lottery method.
The participants of Group A will be managed by Mulligan's spinal mobilization with leg movement while in Group B, participants will receive mechanical lumbar traction.
The physiotherapists will provide both interventions during a specified period.
Blindness: A single blinded study in which patients will be blinded.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
30
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Middle Age 25 to 50 years
- Both male and female of middle aged
- Subacute or chronic lumbar radiculopathy lasting 4 to 12 weeks
- Clinically diagnosed lumbar spine radiculopathy
- Pain radiating from lumbar region to the leg in one or more dermatomal distribution of the lumbosacral nerve root
- Moderate functional disability as indicated by Oswestry Disability Index (ODI) >20%
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Acute pain (<4 weeks)
- Contraindications to manual therapy or traction such as spinal instability
- significant musculoskeletal conditions, cerebrovascular accidents, psychiatric illness, or major systemic illness
- Neurological compromised, other radicular pain (e.g., piriformis syndrome, diabetic radiculopathy, vascular impingement of the sciatic nerve)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Spinal Mobilization With Leg Movement
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Group A: Mulligan's spinal mobilization with leg movement with Conventional Therapy Patient Position: The participants were positioned in a side-lying position on their unaffected side, close to the edge of the treatment table.
Therapist Position: The affected leg was supported by therapist B and extended with a slight abduction of 10° at the hip and a knee flexion of 45°.Application of Technique: Therapist A applied and sustained a transverse glide of the spinous process toward the floor.
The participants actively moved the leg into the SLR with therapist B's assistance.
The L4 vertebra was selected if the participant had an L4/L5 lesion.
Therapist A carefully assisted the participants to perform active SLR in a gliding position with the help of therapist B to avoid symptom recurrence during movement.
If pain recurred, the participant was instructed to relax and hold the position for 3 s, and then return to the starting point(29).
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Aktiver Komparator: conventional therapy
5 minutes conventional therapy with patient education will be given to participants of both groups according to the severity of their condition along with allocated intervention.
This includes; directional preference exercises (e.g., McKenzie), core activation exercises, trunk and hip muscles strengthening and neurodynamic mobilization if nerve symptoms persist.
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Group B: Mechanical Lumbar Traction with Conventional Therapy Patient Position: Patient position supine (lying on the back) with hips and knees flexed (pillows under the knees).
However, prone (lying on the stomach) positioning can also be utilized, particularly when the patient experiences discomfort or when targeting anterior structures of the spine.
Traction Technique: Mechanical lumbar traction is a technique that uses a machine to apply a controlled, distracting force to the lumbar spine.
This can help relieve pressure on the spinal nerves, reduce muscle spasms, and improve spinal alignment.
It's typically performed using a traction table and harnesses to gently pull the lower body away from the upper body.
Duration: For lumbar traction, sessions usually range from 20 to 30 minutes, with a frequency of several times per week(30).
Warm Up: 5minutes warm-up will be given before intervention to participants of both groups.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
numeric pain rating scale
Zeitfenster: Baseline to 4 weeks
|
NUMERIC PAIN RATING SCALE (NPRS) The Numeric Rating Scale (NRS) is a validated tool used to measure pain intensity.
Patients will be asked to rate their current pain severity on a scale from 0 to 10. Scoring can be obtained by calculating the mean score over a period of time or by tracking individual scores
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Baseline to 4 weeks
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Lumbar Mobility
Zeitfenster: Baseline to 4 weeks
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OSWESTRY DISABILITY INDEX (ODI) The ODI is a ten-item questionnaire that assesses how back pain affects the patient's ability to perform daily activities of life (ADL).
It is a reliable and valid self-reported questionnaire that lasts 5 min for the patient to complete the measure and a few minutes for the examiner to calculate the scores.
Each item is scored from 0 to 5, and the summation of the ten scores is stated as a percentage of the maximum score; therefore, it ranges from 0 (no disability) to 100 (maximum disability)
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Baseline to 4 weeks
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Functional Disability
Zeitfenster: Baseline to 4 weeks
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MODIFIED MODIFIED SCHOBER TEST (MMST) The Modified Modified Schober Test (MMST) is a clinical assessment of lumbar spine mobility where two marks are made on the patient's back-one at the midpoint between the posterior superior iliac spines (PSIS) and another 15 cm above it.
The patient then bends forward maximally, and the increase in distance between the marks is measured; a normal increase is ≥5 cm, while reduced expansion suggests restricted lumbar flexion, as seen in conditions like ankylosing spondylitis, degenerative disc disease, or radiculopathy.
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Baseline to 4 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Tazeem Afzal, Ms, Riphah International University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. Juni 2025
Primärer Abschluss (Geschätzt)
6. August 2026
Studienabschluss (Geschätzt)
4. September 2026
Studienanmeldedaten
Zuerst eingereicht
8. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Juni 2026
Zuerst gepostet (Tatsächlich)
11. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REC/RCR & AHS/25/0212
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Beschreibung des IPD-Plans
nill
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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