NCT05334394

Brief Summary

This study was aimed to investigate the effectiveness of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain and to compare it with exercise.37 patients aged between 18-65 who applied to Fındıkzade Medipol Hospital were included in the study. The individuals participating in the study were divided into two groups, 18 control and 19 mulligan groups, according to the randomization table. The intervention was performed 3 times a week for 4 weeks. Conventional physiotherapy and exercise program accompanied by a physiotherapist were applied to the control group, and conventional physiotherapy and mulligan mobilization technique were applied to the mulligan group. Conventional physiotherapy methods included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS), and hotpack. The patients were evaluated with TecnoBody Static Balance Device, algometer, electrogoniometer, visual analog scale, Oswestry Low Back Pain Disability Questionnaire before and after the treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

April 4, 2022

Last Update Submit

April 12, 2022

Conditions

Keywords

BalanceChronic Low Back PainExerciseLumbal Disc HerniationManual TherapyMulligan Mobilization

Outcome Measures

Primary Outcomes (3)

  • TecnoBody Static Balance Device Measurements

    TecnoBody Stability Easy is a stabilometric system consisting of three highly sensitive sensors. The system is based on continuous observation of the foot pressure center (COP). By recording the postural oscillations of the body as a function of time, detailed information about the postural system is obtained

    5 Minutes

  • Pressure Pain-Threshold Measurements with Algometer

    It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.

    5 Minutes

  • Electrogoniometer

    It is an evaluation tool used to record the objective measurement of joint range of motion.

    5 Minutes

Secondary Outcomes (2)

  • Visual Analog Scale

    1 Minutes

  • Oswestry Disability Index

    10 Minutes

Study Arms (2)

Mulligan Group

EXPERIMENTAL
Other: Mulligan Technique

Control Group

EXPERIMENTAL
Other: Exercise Therapy

Interventions

Mulligan suggested that injuries or sprains can cause a minor positional error in a joint, thereby causing limitations in physiological movement. Unique to this concept is mobilization of the spine while weight bearing and directing the mobilization parallel to the spinal facet planes. Although it includes various mobilization techniques, one of the most important techniques, motion co-mobilization, is the SNAG's technique, which includes the application of accessory passive gliding to the lumbar vertebra while the patient performs active movement simultaneously.

Mulligan Group

Exercise is recommended by physical therapists for most chronic low back pain patients.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing non-specific chronic low back pain for more than 3 months
  • The diagnosis has been confirmed by the Health Board Report
  • Be over 18 years old
  • Be younger than 65 years old
  • Pain of at least 2 severity according to VAS
  • Voluntarily agree to participate in the study

You may not qualify if:

  • Previous lumbar trauma or operation
  • Long-term use of corticosteroids
  • Cancer
  • Pregnancy
  • Osteoporosis
  • Systemic Diseases
  • Spinal Deformities
  • Lumbal Stenosis
  • Ankylozone Spondylitis
  • Spondylolisthesis
  • Spinal Deformities
  • Lumbal Stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fındıkzade Medipol Hospital

Istanbul, Fındıkzade, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Kübra Bali, Licenced

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 19, 2022

Study Start

July 10, 2021

Primary Completion

February 1, 2022

Study Completion

February 15, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations