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RecruitingNCT05931653Updated Jan 19, 2024

Multimodal PT With and Without Proprioceptive Training in Lumber FJS

An interventional study of Multimodal Physical therapy and Proprioceptive training along with and Multimodal Physical therapy in Facet Joint Pain, sponsored by Riphah International University. Recruiting at 3 sites in Pakistan. Open to participants aged 25 Years to 53 Years. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 53 Years
Sex
All
01

Study summary

This will be a randomized clinical trial. The study will be conducted at Pakistan Railways General Hospital Rawalpindi and Riphah International Hospital Islamabad. Patients with FJS will be included. The aim of this study is to find the comparative effects of multimodal physical therapy treatment and proprioceptive training along with multimodal physical therapy treatment on pain, lumbar ranges of motion, disability, fatigue, lumbar lordosis curvature and balance.

Participants will be assessed for pain, lumbar range of motions, lumbar lordosis, disability, fatigue and balance before treatment. The intervention duration is 06 weeks, 03 sessions per week will be given to all participants. Pain and lumbar ranges of motion will be measured on every visit. At the end of 06th week final readings for functional status, fatigue level, lumbar lordosis angle, fall risk and limits of stability will also be recorded. Data will be analyzed by SPSS v.23.

02

Conditions studied

  • Facet Joint Pain

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Keywords

  • Low back pain
  • Facet joint
  • Range of motion
  • Balance
  • Fatigue
  • Lordosis
03

In context

Arthralgia

273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.

This study's planned enrollment of 50 is below the median of 63 across 219 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 53 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with facet joint syndrome diagnosed by standard criteria. This criterion includes:

    • One point tenderness under X-ray radiography
    • Kemp sign.
    • Catching pain.
    • Pain increases with lumbar extension.
    • Pain with bilateral SLR.
    • Or pain diminishes with Medial branch block or Facet joint block.
    • Provocation Maneuver. Acevedo sign (Facet stress sign) Unilateral facet palpation Percussion spinal test Impaired range of motion Jump test
    • Revel's criteria 05 out of 07- 1. age greater than 65 years and pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension-rotation, and well-relieved by recumbency.

Standing flexion, returning from standing flexion, standing extension, the extension rotation test.

  • On Biodex balance system (BBS), overall stability index between 0.7-2.8.
  • On Biodex balance system (BBS) Limits of stability Anterior: less than 80, posterior: less than 40 and lateral: less than 160 (80 on each side) 75% LOS (moderate level).
  • NPRS ratings greater than 4
  • Constant or Intermittent pain worsening on repeated movements

Exclusion criteria

Exclusion Criteria:

  • T-score of -2.5 or lower.
  • BMI is 30.0 or higher.
  • Patients with Lumbar Postural Syndrome
  • Patients with Lumbar Instability
  • Post laminectomy/discectomy
  • Spondylolisthesis
  • Osteoporosis/Fractures
  • Cauda equine syndrome
  • Recent history of spinal trauma or surgery
  • Lumbar myelopathy
  • Patients with known metabolic diseases
  • Participants having less than 20% ODI scoring
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Multimodal Physical Therapy

    Multimodal Physical therapy/Traditional Physical therapy

    Other: Multimodal Physical therapy

  • Experimental
    Proprioceptive training along with Multimodal Physical Therapy

    Proprioceptive training along with Multimodal Physical Therapy

    Other: Proprioceptive training along with and Multimodal Physical therapy

Interventions

  • OtherMultimodal Physical therapy

    • Multimodal Physical therapy: Hot pack for 15 mins, TENS for 15 mins, Ultrasound at 1.5 W/cm2 intensity for 5 mins, Soft tissue release for \<5-15 mins as per need, HVLA, PA Glides (Central and Transverse mobilizations) (10 sec each) x5 sets, Lumbar facet gapping (LFG) in side lying (10 sec 3 sets) and Lumbar rotational facet gapping (LRFG) in side lying (10 sec 3 sets). 03 days/week for 06 weeks.

  • OtherProprioceptive training along with and Multimodal Physical therapy

    * Multimodal Physical Therapy: Hot pack-5 mins, TENS-5 mins, U.S (1.5 W/cm2)-5 mins, Soft tissue release-\<5-15 mins, HVLA, PA Glides (Central and Transverse)-10 sec each 5 sets, Lumbar facet gapping-10 sec 3 sets and Lumbar rotational facet gapping-10 sec 3 sets. 3 days/week for 6 weeks. * Proprioceptive Training:1. Trunk Balance (15 mins). In sitting, kneeling, quadruped, and supine positions for 30 seconds to 2 minutes. Progression to more challenging. Each will be performed for 2-3 mins. In case of pain exercise will be interrupted and substituted with another one. 2. PNF Training (10-12 mins). Each PNF training-1 set of 15 reps with 30s rest between and 60s after 15 reps. Week 1-2 alternate full isometrics of trunk flexors and extensors for 10s in sitting. Week 3-4, 5s resisted concentric, 5s eccentric and 5s isometrics contractions in forward and backward bending. Week 5-6, alternate chop and lift movement patterns of upper extremities in diagonal and spiral directions for 10s.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale

    Changes from base Line Visual Analogue Rating (VAS) is a self-report of clinical pain intensity. The scale was 10 cm long and anchored by the statements "no pain" (0-4 mm) on the left mild pain (5-44 mm), moderate pain (45-74 mm), and the most intense pain imaginable (75-100 mm) on the right.

    Time frame: 6th week

  2. Bubble Inclinometer

    Changes from base Line Bubble inclinometers assess range of motion like a goniometer. The 12th thoracic and 1st sacral vertebrae will be taken as the reference points for lumbar flexion and extension.

    Time frame: 6th week

  3. Lateral view X-ray and Kinovea software

    Changes from base Line Angle of lumbar lordosis will be measures by plane X-ray lateral view and angle will be measured by Kinovea software for windows platform.

    Time frame: 6th week

  4. Modified Oswestry Disability Index (MODI) Urdu Version

    Changes from base Line MODI is a measure of disability in low back pain. It is divided into ten sections that assess the level of pain and interference with physical activities such as sleeping, standing, walking, home making, social life and traveling. Each question has a possible six responses which are scored from 0 to 5. The score for each section is added and divided by the total possible score (fifty if all sections are completed), with the resulting score multiplied by a hundred to yield a percentage score with 0% equivalent to no disability and 100% equivalent to a great deal of disability.

    Time frame: 6th week

  5. Limits of stability by Biodex Balance System (BBS)

    Changes from base Line In testing mode of BBS Score be calculated at moderate difficulty level (75%-default set value). This test challenges patients to move and control their center of gravity within their base of support. Patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets. Targets on the screen blink in random order.

    Time frame: 6th week

  6. Fall Risk Scoring by Biodex Balance System (BBS)

    Changes from base Line Normal actual score range of fall risk index for individuals ranging 17 to 53 years of age is 0.7 to 2.8. The closer an individual to this actual core range, he/she is considered more stable with reduction in fall risk.

    Time frame: 6th week

  7. Fatigue by Fatigue Assessment Scale (FAS)

    Changes from base Line Every point of the fatigue assessment scale has further five components in which 1 means "never" and 5 means "always" Its scoring is from 10-50 in which 10 showing lowest fatigue level and 50 means indicating highest fatigue level. The fatigue assessment scale total count can be obtained by adding the numbers obtained of the queries altogether. If the overall score is less than 22 it denotes no fatigue, more than 22 it will show fatigue. 10-21 Score of FAS: fatigue is not present. 22-50 score of FAS: the presence of substantial fatigue.

    Time frame: 6th week

07

Study locations

1 of 3 sites recruiting
  • Riphah Rehabilitation Center
    Rawalpindi, Punjab 46000, Pakistan
    • Muhammad Affan A Iqbal, MS-OMPT* · Contact · affan.iqbal@riphah.edu.pk · 03336754837
    • Muhammad Affan Iqbal, PhD* · Principal investigator
    Not yet recruiting
  • Pakistan Railways General Hospital
    Rawalpindi, Punjab 46060, Pakistan
    Not yet recruiting
  • The Health Professionals
    Rawalpindi, Punjab 46220, Pakistan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05931653
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 5, 2023
Start date
May 1, 2023
Primary completion
May 30, 2024 (estimated)
Completion
Nov 15, 2024 (estimated)
Last update
Jan 19, 2024

Study contacts

Imran Amjad, PhD
Contact
imran.amjad@riphah.edu.pk
03324390125
Syed Shakil-Ur-Rehman, PhD
Contact
shakil.urrehman@riphah.edu.pk
03207866611
Muhammad Affan Iqbal, PhD*
principal investigator · Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
Syed A Shakil-Ur-Rehman, PhD
study chair · Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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