NCT06076408

Brief Summary

The aim of this study is to compare the effects of Sustained Natural Apophyseal Glides with and without Pilates on pain, range of motion and disability in patients with lumbar Disc Bulge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

October 4, 2023

Last Update Submit

April 7, 2025

Conditions

Keywords

disabilitylumbar radiculopathylow back painendurance

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    NPRS scale can be used to quantify pain intensity levels. The 11-point scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10. "change will be measured from baseline to 3 weeks"

    3 weeks

  • Modified Oswestry Disability Index

    The ODI is a disease specific disability measure is used to establish measure a level of disability stage of patients' acuity status and monitor change over time. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. "Change will be measured from baseline to 3 weeks"

    3 weeks

  • Lumbar ROM by inclinometer

    Inclinometer is used to measure the range of motion on Lumbar spine. "Change in ROM will be measured from baseline to 3 weeks".

    3 weeks

Study Arms (2)

SNAGS with Pilates

EXPERIMENTAL

Sustained Natural Apophyseal glides and Pilates Exercises

Other: SNAGS with Pilates

SNAGS

ACTIVE COMPARATOR

Sustained Natural Apophyseal glides

Other: SNAGS

Interventions

Patients will Receive Sustained Natural Apophyseal glides and Pilates Technique. Pilates Exercises focusses on five main areas (breath control, pelvic lumbar region, chest, shoulder positioning, head and neck positioning) a special session was organized for each patient

SNAGS with Pilates
SNAGSOTHER

Patients will Receive Sustained Natural Apophyseal glides

SNAGS

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient of both gender under the age of 40-60 year.
  • Unilateral radiating pain through the course of sciatic nerve
  • a duration of pain of at least 3 months
  • Restricted lumbar range of motion.
  • Subjects who can understand the instructions and are willing to participate in the study
  • Positive slump test with positive pain location and positive pain descriptors.
  • Passive Lumbar Extension If the patient experiences severe low back pain or if there is a feeling of heaviness on the lower back or a feeling as though the lower back were about to 'come off' the test is considered positive.
  • Straight Leg Raise SLR test positive when it evokes radiating pain along the course of the sciatic nerve and below the knee between 30 and 70 degrees of hip flexion

You may not qualify if:

  • History of trauma, dislocation and subluxation of lower extremity.
  • Rheumatoid Arthritis
  • Systemic diseases such as blood coagulation disorders, chronic pain syndrome, cancer, allergies fibromyalgia, systemic lupus erythematous, and psoriatic arthritis.
  • Lumbar spine surgery patients.
  • Malignancy
  • neurologic disorders (e.g., trigeminal neuralgia or occipital neuralgia)
  • clinical diagnosis of lumbar bilateral radiculopathy or myelopathy
  • history of previous physical therapy intervention for the lumbar region in last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakhtawar Amin Hospital Multan

Multan, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementRadiculopathyLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Faiza Ashraf, TDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Ammar Javed, MS OMPT*

    Riphah International 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
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

October 3, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations