Lumbar RadiculopathyNCT05922228
Effects of Neural Flossing and PNF on Lumbar Radiculopathy
A study testing neural flossing with proprioceptive neuromuscular facilitation and Neural flossing without proprioceptive neuromuscular facilitation in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
the goal of this clinical trial is to determine the effects of neural flossing with and without proprioceptive neuromuscular facilitation on pain, range of motion and disability in patients with lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- neural flossing with proprioceptive neuromuscular facilitation and Neural flossing without proprioceptive neuromuscular facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Nov 2022to 1 Oct 2023
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 35-50 years.
- Both males and females.
- Pain intensity is 4 out of 10 on numeric pain rating scale.
- History of radiculopathy for more than 3 weeks.
- Pain radiating below to knee.
Who cannot join
- Cognitive impairment.
- Using pain modulating medicines.
- Patients with comorbidities.
- Pain radiating above to knee.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aziz Bhatti Shaheed Teaching Hospital
Dhok Gujra, Punjab Province, 50700
wajiha shahid, PhD, 03214885079, wajiha.shahid@riphah.edu.pk
atif chaudhary, MS-NMPT*
About this study
Official title: Effects of Neural Flossing With and Without Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Disability in Patients With Lumbar Radiculopathy.
the goal of this clinical trial is to determine the effects of neural flossing with and without proprioceptive neuromuscular facilitation on pain, range of motion and disability in patients with lumbar radiculopathy. the main question it aim to answer is :- Does proprioceptive neuromuscular facilitation added benefit when combined with neural flossing to pain, range of motion and disability in lumbar radiculopathy patients? Research will compare the neural flossing group with the group receiving neural flossing with proprioceptive neuromuscular facilitation to see if there is any difference in the outcomes.
Read the detailed description
Lumbar radiculopathy is a mutual condition amongst persons presenting to a spinal physician for consultation. Lumbar radiculopathy is a term used to describe the pain that is started in low back and radiated along the nerve root. The patient mostly complains from a low back pain that radiates toward the legs. Symptoms may include radiating pain, weakness, hypo-reflexia and gait abnormalities. The pain is caused by the neurological manifestations of a compressive force along a specific nerve route. The main cause of radiculopathy is compression or irritation of nerve root exited from spinal cord. Lumbar radiculopathy can affect anyone regardless of their age, gender, race and geographical locality. About 40% people developed low back pain at some points in their life and out of them 3-5% population developed lumbar radiculopathy.
A study conducted to find out the influence of nerve flossing technique on acute sciatica and hip range of motion with sample size of 32. It was concluded that as a result of nerve flossing technique since no statistically significant changes occurred between the two groups. Hence, for effective reduction of sciatic pain and possible improvement in hip range of motion, nerve flossing technique should be combined with conventional physiotherapy. A study conducted on mobilization of Neurodynamic system using proprioceptive neuromuscular facilitation (PNF) decrease pain and increase mobility in lower extremities and spine suggested that PNF based rehabilitation approach results in improvement of pain, nerve mobility and balance.it also has positive effects by supplying oxygen to nerve, increase nerve mobility and decrease pain.
Some studies have been done testing the effects of neural flossing technique and PNF techniques individually as a treatment option for lumbar radiculopathy. But, up to the researcher's knowledge there is little literature on comparing both treatments with respect to pain, range of motion and disability in lumbar radiculopathy.
- Conditions
- Lumbar Radiculopathy
- Being tested
- neural flossing with proprioceptive neuromuscular facilitation, Neural flossing without proprioceptive neuromuscular facilitation
- Keywords
- Disability, Lumbar, PNF, Neural flossing, pain
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural flossing with proprioceptive neuromuscular facilitationOther
neural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week contract relax technique of proprioceptive neuromuscular facilitation for 5 minutes, 10 repetitions ×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 10 minutes
Neural flossing without proprioceptive neuromuscular facilitationOther
neural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Neural flossing with proprioceptive neuromuscular facilitation | Experimental | nerve flossing technique protocol along with contract relax technique of proprioceptive neuromuscular facilitation is used Receives: Other: neural flossing with proprioceptive neuromuscular facilitation |
| Neural flossing without proprioceptive neuromuscular facilitation | Active comparator | only nerve flossing technique protocol is used Receives: Other: Neural flossing without proprioceptive neuromuscular facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
It is a common pain screening tool use to assess the severity of pain at moment time. It is 0-10 scale where 0 means no pain and 10 means worst pain imaginable.
Measured: 5 weeks
Goniometer
It is an instrument used to measure the available range of motion at joints. It is most commonly used tool to measure the range of motion of joints by physiotherapists.
Measured: 5 weeks
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start11 Nov 2022
- Primary completion15 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922228
- Sponsor's protocol ID
- REC/RCR&AHS/23/0212
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
PubMed 22543563Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
PubMed 21665125Ghasabmahaleh SH, Rezasoltani Z, Dadarkhah A, Hamidipanah S, Mofrad RK, Najafi S. Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial. Am J Med. 2021 Jan;134(1):135-141. doi: 10.1016/j.amjmed.2020.08.005. Epub 2020 Sep 13.
PubMed 32931763Senol D, Erdem C, Canbolat M, Toy S, Karatas T, Baykara RA, Ozbag D, Akyurek G. Comparison of the effects of conventional physiotherapy and proprioception exercises on pain and ankle proprioception in patients with lumbar radiculopathy. J Back Musculoskelet Rehabil. 2022;35(2):421-428. doi: 10.3233/BMR-200361.
PubMed 34308899Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
PubMed 30074971Kahlaee AH, Ghamkhar L, Arab AM. The Association Between Neck Pain and Pulmonary Function: A Systematic Review. Am J Phys Med Rehabil. 2017 Mar;96(3):203-210. doi: 10.1097/PHM.0000000000000608.
PubMed 27610549Luoto S, Taimela S, Hurri H, Aalto H, Pyykko I, Alaranta H. Psychomotor speed and postural control in chronic low back pain patients A controlled follow-up study. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2621-7. doi: 10.1097/00007632-199611150-00012.
PubMed 8961450Newcomer KL, Jacobson TD, Gabriel DA, Larson DR, Brey RH, An KN. Muscle activation patterns in subjects with and without low back pain. Arch Phys Med Rehabil. 2002 Jun;83(6):816-21. doi: 10.1053/apmr.2002.32826.
PubMed 12048661Barden JM, Balyk R, Raso VJ, Moreau M, Bagnall K. Dynamic upper limb proprioception in multidirectional shoulder instability. Clin Orthop Relat Res. 2004 Mar;(420):181-9. doi: 10.1097/00003086-200403000-00025.
PubMed 15057095Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
PubMed 30582917
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neural Flossing With and Without Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Disability in Patients With Lumbar Radiculopathy.
- ClinicalTrials.gov ID
- NCT05922228
- Acronym / sponsor ID
- REC/RCR&AHS/23/0212
- Conditions
- Lumbar Radiculopathy
- Keywords
- Disability, Lumbar, PNF, Neural flossing, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 28 Jun 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.
the goal of this clinical trial is to determine the effects of neural flossing with and without proprioceptive neuromuscular facilitation on pain, range of motion and disability in patients with lumbar radiculopathy. the main question it aim to answer is :- Does proprioceptive neuromuscular facilitation added benefit when combined with neural flossing to pain, range of motion and disability in lumbar radiculopathy patients? Research will compare the neural flossing group with the group receiving neural flossing with proprioceptive neuromuscular facilitation to see if there is any difference in the outcomes.
Detailed description
Lumbar radiculopathy is a mutual condition amongst persons presenting to a spinal physician for consultation. Lumbar radiculopathy is a term used to describe the pain that is started in low back and radiated along the nerve root. The patient mostly complains from a low back pain that radiates toward the legs. Symptoms may include radiating pain, weakness, hypo-reflexia and gait abnormalities. The pain is caused by the neurological manifestations of a compressive force along a specific nerve route. The main cause of radiculopathy is compression or irritation of nerve root exited from spinal cord. Lumbar radiculopathy can affect anyone regardless of their age, gender, race and geographical locality. About 40% people developed low back pain at some points in their life and out of them 3-5% population developed lumbar radiculopathy.
A study conducted to find out the influence of nerve flossing technique on acute sciatica and hip range of motion with sample size of 32. It was concluded that as a result of nerve flossing technique since no statistically significant changes occurred between the two groups. Hence, for effective reduction of sciatic pain and possible improvement in hip range of motion, nerve flossing technique should be combined with conventional physiotherapy. A study conducted on mobilization of Neurodynamic system using proprioceptive neuromuscular facilitation (PNF) decrease pain and increase mobility in lower extremities and spine suggested that PNF based rehabilitation approach results in improvement of pain, nerve mobility and balance.it also has positive effects by supplying oxygen to nerve, increase nerve mobility and decrease pain.
Some studies have been done testing the effects of neural flossing technique and PNF techniques individually as a treatment option for lumbar radiculopathy. But, up to the researcher's knowledge there is little literature on comparing both treatments with respect to pain, range of motion and disability in lumbar radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural flossing with proprioceptive neuromuscular facilitation | Experimental | Other: neural flossing with proprioceptive neuromuscular facilitationnerve flossing technique protocol along with contract relax technique of proprioceptive neuromuscular facilitation is used |
| Neural flossing without proprioceptive neuromuscular facilitation | Active comparator | Other: Neural flossing without proprioceptive neuromuscular facilitationonly nerve flossing technique protocol is used |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 35-50 years.
- Both males and females.
- Pain intensity is 4 out of 10 on numeric pain rating scale.
- History of radiculopathy for more than 3 weeks.
- Pain radiating below to knee.
Key exclusion criteria (4 listed)
- Cognitive impairment.
- Using pain modulating medicines.
- Patients with comorbidities.
- Pain radiating above to knee.
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 |
|---|---|---|
| neural flossing with proprioceptive neuromuscular facilitationneural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week contract relax technique of proprioceptive neuromuscular facilitation for 5 minutes, 10 repetitions ×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 10 minutes | Other | Neural flossing with proprioceptive neuromuscular facilitation |
| Neural flossing without proprioceptive neuromuscular facilitationneural flossing technique for 5minutes, 10 repetitions×1 set, 3 days/week total of 15 sessions were given as 3 sessions/week up to 5 weeks, each session consisting of 5 minutes | Other | Neural flossing without proprioceptive neuromuscular facilitation |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 5 weeks
It is a common pain screening tool use to assess the severity of pain at moment time. It is 0-10 scale where 0 means no pain and 10 means worst pain imaginable.
Goniometer
Time frame: 5 weeks
It is an instrument used to measure the available range of motion at joints. It is most commonly used tool to measure the range of motion of joints by physiotherapists.
Oswestry Disability Index (ODI)
Time frame: 5 weeks
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 22543563Schoenfeld AJ, Laughlin M, Bader JO, Bono CM. Characterization of the incidence and risk factors for the development of lumbar radiculopathy. J Spinal Disord Tech. 2012 May;25(3):163-7. doi: 10.1097/BSD.0b013e3182146e55.
- Background: PubMed 21665125Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
- Background: PubMed 32931763Ghasabmahaleh SH, Rezasoltani Z, Dadarkhah A, Hamidipanah S, Mofrad RK, Najafi S. Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial. Am J Med. 2021 Jan;134(1):135-141. doi: 10.1016/j.amjmed.2020.08.005. Epub 2020 Sep 13.
- Background: PubMed 34308899Senol D, Erdem C, Canbolat M, Toy S, Karatas T, Baykara RA, Ozbag D, Akyurek G. Comparison of the effects of conventional physiotherapy and proprioception exercises on pain and ankle proprioception in patients with lumbar radiculopathy. J Back Musculoskelet Rehabil. 2022;35(2):421-428. doi: 10.3233/BMR-200361.
- Background: PubMed 30074971Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822.
- Background: PubMed 27610549Kahlaee AH, Ghamkhar L, Arab AM. The Association Between Neck Pain and Pulmonary Function: A Systematic Review. Am J Phys Med Rehabil. 2017 Mar;96(3):203-210. doi: 10.1097/PHM.0000000000000608.
- Background: PubMed 8961450Luoto S, Taimela S, Hurri H, Aalto H, Pyykko I, Alaranta H. Psychomotor speed and postural control in chronic low back pain patients A controlled follow-up study. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2621-7. doi: 10.1097/00007632-199611150-00012.
- Background: PubMed 12048661Newcomer KL, Jacobson TD, Gabriel DA, Larson DR, Brey RH, An KN. Muscle activation patterns in subjects with and without low back pain. Arch Phys Med Rehabil. 2002 Jun;83(6):816-21. doi: 10.1053/apmr.2002.32826.
- Background: PubMed 15057095Barden JM, Balyk R, Raso VJ, Moreau M, Bagnall K. Dynamic upper limb proprioception in multidirectional shoulder instability. Clin Orthop Relat Res. 2004 Mar;(420):181-9. doi: 10.1097/00003086-200403000-00025.
- Background: PubMed 30582917Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
- 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.
Wajiha Shahid, phd principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neural flossing with proprioceptive neuromuscular facilitation and Neural flossing without proprioceptive neuromuscular facilitation in people with Lumbar Radiculopathy, run by Riphah International University at 1 site 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 5 inclusion and 4 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wajiha Shahid, phd (03214885079, wajiha.shahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922228, which also lists 10 linked publications.
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 28 Jun 2023.