Facet Joint PainNCT05931653
Multimodal PT With and Without Proprioceptive Training in Lumber FJS
A study testing Multimodal Physical therapy and Proprioceptive training along with and Multimodal Physical therapy in people with Facet Joint Pain, run by Riphah International University at 3 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 53 years
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- Multimodal Physical therapy and Proprioceptive training along with and Multimodal Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesPakistan
- Study dates
- 1 May 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites, 3 recruiting
- Not yet recruiting
Riphah Rehabilitation Center
Rawalpindi, Punjab Province, 46000
Muhammad Affan A Iqbal, MS-OMPT*, 03336754837, affan.iqbal@riphah.edu.pk
Muhammad Affan Iqbal, PhD*
- Not yet recruiting
Pakistan Railways General Hospital
Rawalpindi, Punjab Province, 46060
Muhammad Affan Iqbal, PhD*, 0333-6754837, affan92@gmail.com
Abdul Wasay, MSPT, 03345056564, abdulwasay.nafe@riphah.edu.pk
- Recruiting
The Health Professionals
Rawalpindi, Punjab Province, 46220
Muhammad Affan Iqbal, PhD, 03336754837, affan.iqbal@riphah.edu.pk
Uzair Khalid, MS-OMPT, 03365264781, shuzair.khalid@gmail.com
About this study
Official title: Multimodal Physical Therapy Approach With and Without Proprioceptive Training in Lumber Facet Joint Syndrome.
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.
- Conditions
- Facet Joint Pain
- Being tested
- Multimodal Physical therapy, Proprioceptive training along with and Multimodal Physical therapy
- Keywords
- Low back pain, Facet joint, Range of motion, Balance, Fatigue, Lordosis
- Medical subject headings
- Low Back Pain, Fatigue, Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Physical therapyOther
- 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.
Proprioceptive training along with and Multimodal Physical therapyOther
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physical Therapy | Experimental | Multimodal Physical therapy/Traditional Physical therapy Receives: Other: Multimodal Physical therapy |
| Proprioceptive training along with Multimodal Physical Therapy | Experimental | Proprioceptive training along with Multimodal Physical Therapy Receives: Other: Proprioceptive training along with and Multimodal Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 May 2023
- Primary completion30 May 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah College of Rehabilitation and Allied Health Sciences, Riphah International UniversitySyed A Shakil-Ur-Rehman, PhD, Study chair, Riphah College of Rehabilitation and Allied Health Sciences, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931653
- Sponsor's protocol ID
- REC/RCR&AHS/23/1102
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Physical Therapy Approach With and Without Proprioceptive Training in Lumber Facet Joint Syndrome.
- ClinicalTrials.gov ID
- NCT05931653
- Acronym / sponsor ID
- REC/RCR&AHS/23/1102
- Conditions
- Facet Joint Pain
- Keywords
- Low back pain, Facet joint, Range of motion, Balance, Fatigue, Lordosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physical Therapy | Experimental | Other: Multimodal Physical therapyMultimodal Physical therapy/Traditional Physical therapy |
| Proprioceptive training along with Multimodal Physical Therapy | Experimental | Other: Proprioceptive training along with and Multimodal Physical therapyProprioceptive training along with Multimodal Physical Therapy |
Who may qualify
- Ages
- 25 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients with facet joint syndrome diagnosed by standard criteria. This criterion includes:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal 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. | Other | Multimodal Physical Therapy |
| Proprioceptive 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. | Other | Proprioceptive training along with Multimodal Physical Therapy |
Primary outcome
Visual Analogue Scale
Time frame: 6th week
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.
Bubble Inclinometer
Time frame: 6th week
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.
Lateral view X-ray and Kinovea software
Time frame: 6th week
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.
Modified Oswestry Disability Index (MODI) Urdu Version
Time frame: 6th week
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.
Limits of stability by Biodex Balance System (BBS)
Time frame: 6th week
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.
Fall Risk Scoring by Biodex Balance System (BBS)
Time frame: 6th week
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.
Fatigue by Fatigue Assessment Scale (FAS)
Time frame: 6th week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physical therapy and Proprioceptive training along with and Multimodal Physical therapy in people with Facet Joint Pain, run by Riphah International University at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 6th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.