Lumbar RadiculopathyNCT06707779
PNF With and Without Electrical Stimulation in Patients With Chronic Lumbar Radiculopathy
A study testing PNF with electrical stimulation and PNF without electrical stimulation in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Numerous researches have shown how PNF is been used to treat non specific low back pain, subacromial impingement, cervical radiculopathy and many others. In some studies different techniques like Mckenzie method, spinal mobilization and Mulligan traction other than PNF were being used to treat lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- PNF with electrical stimulation and PNF without electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Feb 2024to 31 Oct 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Diagnosed cases of lumbar radiculopathy
- Either one or both legs affected by radiating pain
- Signs of nerve root compression like paresthesia, numbness, tingling, sharp pain
- Impaired deep tendon reflex(knee jerk, ankle jerk)
- Both male and female
- Radiological evidence of lumbar spondylosis with radiculopathy
Show all 10Show fewer
- Age group between 40 to 70 years
- Positive SLR test between 45° to 70°
- All subjects with symptoms for duration of more than 6 weeks
- Increase leg pain by coughing and sneezing
Who cannot join
- Serious spinal conditions e.g infection, tumor, osteoporosis
- Uncontrolled hypertension
- Severe cognitive impairment
- Other neurological conditions and systemic illness like kidney and visceral diseases
- Vertebral fracture and spondylolisthesis
- Pregnant women
- History of spinal surgery in previous 6 months
- Clinical conditions such as oversensitive skin, patients with cardiac pacemakers where application of TENS is contraindicated
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Amin welfare and teaching hospital , Awan center
Sialkot, Punjab Province, 51310
About this study
Official title: Effect of Proprioceptive Neuromuscular Facilitation With and Without Electrical Stimulation on Pain and Functional Disability in Patients With Chronic Lumbar Radiculopathy
Numerous researches have shown how PNF is been used to treat non specific low back pain, subacromial impingement, cervical radiculopathy and many others. In some studies different techniques like Mckenzie method, spinal mobilization and Mulligan traction other than PNF were being used to treat lumbar radiculopathy. According to researchers knowledge little literature available to see the effectiveness of PNF with electrical stimulation in patients with chronic lumbar radiculopathy. Therefore, the purpose of the current study is to examine the effects of PNF with electrical stimulation in patients with chronic lumbar radiculopathy.
- Conditions
- Lumbar Radiculopathy
- Being tested
- PNF with electrical stimulation, PNF without electrical stimulation
- Keywords
- pain, disability
- Medical subject headings
- Radiculopathy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF with electrical stimulationOther
Group A receive PNF including combination of isotonic and rhythmic stabilization on trunk with electrical stimulation Participants perform three sets10 repetitions at maximal resistance The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively.
In total all PNF exercise will be held for 30 to 45 minutes. 'BURST' TENS (acupuncture-like TENS), characterized by discontinuous stimulation at low frequencies (1-4 Hz), with wave durations of 100-400 ms and high intensities, inducing weak muscle twitches for 10 minutes.
PNF without electrical stimulationOther
Group B receive PNF including combination of isotonic and rhythmic stabilization on trunk without electrical stimulation. Participants perform three sets of 10 repetitions at maximal resistance will be provided by the same physiotherapist.
The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively.
In total all PNF exercise will be held for 30 to 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PNF with electrical stimulation | Experimental | participants in this arm receive PNF with electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy Receives: Other: PNF with electrical stimulation |
| PNF without electrical stimulation | Experimental | participants in this arm receive PNF without electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy Receives: Other: PNF without electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain numeric rating scale
The pain numeric rating scale is a segmented numeric version of visual analog scale in which a respondent selects a whole number 0 to 10 that reflects the intensity of pain. The 11 point numeric scale ranges from 0 representing no pain and 10 representing extreme pain. Higher scores indicating greater pain intensity. e.g. as bad as you can imagine or worst pain. NPRS takes less than 1 minute to complete and easy to administer and score.
Measured: 6th week
Modified Oswestry disability index
MODI also known as the Oswestry Low Back Pain Disability Questionnaire, as a very crucial instrument to assess a patient's functional disability over the long term. MODI is a patient completed questionnaire included 10 sections of questions. This tool is effective for persistent severe disability. The MODI domains are the following: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and employment/home making. Each section has six statements that are scored from 0 means minimum degree of difficulties in that activity to 5 means maximum degree of difficulty.
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 posted27 Nov 2024
- Study start2 Feb 2024
- Primary completion15 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, PP DPT, Principal investigator, Riphah International University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707779
- Sponsor's protocol ID
- REC/24/0214 Azka Yaseen
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaya DO, Celenay ST, Secer E, Biceroglu H. Pain intensity, spine structure, and body composition in patients with acute discogenic lumbar radiculopathy. Musculoskelet Sci Pract. 2024 Oct;73:103133. doi: 10.1016/j.msksp.2024.103133. Epub 2024 Jul 2.
PubMed 38968681Moustafa IM, Diab AAM, Harrison DE. Does Improvement towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial. J Clin Med. 2022 Sep 29;11(19):5768. doi: 10.3390/jcm11195768.
PubMed 36233636Clark R, Weber RP, Kahwati L. Surgical Management of Lumbar Radiculopathy: a Systematic Review. J Gen Intern Med. 2020 Mar;35(3):855-864. doi: 10.1007/s11606-019-05476-8. Epub 2019 Nov 11.
PubMed 31713029Ghasabmahaleh 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 32931763Samant P, Tawde P, Tawde DN. Understanding How Patients With Lumbar Radiculopathy Make Sense of and Cope With Their Symptoms. Cureus. 2024 Mar 26;16(3):e56987. doi: 10.7759/cureus.56987. eCollection 2024 Mar.
PubMed 38665744Pojskic M, Bisson E, Oertel J, Takami T, Zygourakis C, Costa F. Lumbar disc herniation: Epidemiology, clinical and radiologic diagnosis WFNS spine committee recommendations. World Neurosurg X. 2024 Feb 20;22:100279. doi: 10.1016/j.wnsx.2024.100279. eCollection 2024 Apr.
PubMed 38440379
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proprioceptive Neuromuscular Facilitation With and Without Electrical Stimulation on Pain and Functional Disability in Patients With Chronic Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06707779
- Acronym / sponsor ID
- REC/24/0214 Azka Yaseen
- Conditions
- Lumbar Radiculopathy
- Keywords
- pain, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Nov 2024 (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.
Numerous researches have shown how PNF is been used to treat non specific low back pain, subacromial impingement, cervical radiculopathy and many others. In some studies different techniques like Mckenzie method, spinal mobilization and Mulligan traction other than PNF were being used to treat lumbar radiculopathy. According to researchers knowledge little literature available to see the effectiveness of PNF with electrical stimulation in patients with chronic lumbar radiculopathy. Therefore, the purpose of the current study is to examine the effects of PNF with electrical stimulation in patients with chronic 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 |
|---|---|---|
| PNF with electrical stimulation | Experimental | Other: PNF with electrical stimulationparticipants in this arm receive PNF with electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy |
| PNF without electrical stimulation | Experimental | Other: PNF without electrical stimulationparticipants in this arm receive PNF without electrical stimulation to reduce pain and functional disability in patients with chronic lumbar radiculopathy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Diagnosed cases of lumbar radiculopathy
Key exclusion criteria (8 listed)
- Serious spinal conditions e.g infection, tumor, osteoporosis
- Uncontrolled hypertension
- Severe cognitive impairment
- Other neurological conditions and systemic illness like kidney and visceral diseases
- Vertebral fracture and spondylolisthesis
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 |
|---|---|---|
| PNF with electrical stimulationGroup A receive PNF including combination of isotonic and rhythmic stabilization on trunk with electrical stimulation Participants perform three sets10 repetitions at maximal resistance The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively. In total all PNF exercise will be held for 30 to 45 minutes. 'BURST' TENS (acupuncture-like TENS), characterized by discontinuous stimulation at low frequencies (1-4 Hz), with wave durations of 100-400 ms and high intensities, inducing weak muscle twitches for 10 minutes. | Other | PNF with electrical stimulation |
| PNF without electrical stimulationGroup B receive PNF including combination of isotonic and rhythmic stabilization on trunk without electrical stimulation. Participants perform three sets of 10 repetitions at maximal resistance will be provided by the same physiotherapist. The resting interval of 30 seconds and 60 seconds will be provided after the completion of 10 repetitions for each pattern and between sets respectively. In total all PNF exercise will be held for 30 to 45 minutes. | Other | PNF without electrical stimulation |
Primary outcome
pain numeric rating scale
Time frame: 6th week
The pain numeric rating scale is a segmented numeric version of visual analog scale in which a respondent selects a whole number 0 to 10 that reflects the intensity of pain. The 11 point numeric scale ranges from 0 representing no pain and 10 representing extreme pain. Higher scores indicating greater pain intensity. e.g. as bad as you can imagine or worst pain. NPRS takes less than 1 minute to complete and easy to administer and score.
Modified Oswestry disability index
Time frame: 6th week
MODI also known as the Oswestry Low Back Pain Disability Questionnaire, as a very crucial instrument to assess a patient's functional disability over the long term. MODI is a patient completed questionnaire included 10 sections of questions. This tool is effective for persistent severe disability. The MODI domains are the following: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and employment/home making. Each section has six statements that are scored from 0 means minimum degree of difficulties in that activity to 5 means maximum degree of difficulty.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 38968681Kaya DO, Celenay ST, Secer E, Biceroglu H. Pain intensity, spine structure, and body composition in patients with acute discogenic lumbar radiculopathy. Musculoskelet Sci Pract. 2024 Oct;73:103133. doi: 10.1016/j.msksp.2024.103133. Epub 2024 Jul 2.
- Background: PubMed 36233636Moustafa IM, Diab AAM, Harrison DE. Does Improvement towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial. J Clin Med. 2022 Sep 29;11(19):5768. doi: 10.3390/jcm11195768.
- Background: PubMed 31713029Clark R, Weber RP, Kahwati L. Surgical Management of Lumbar Radiculopathy: a Systematic Review. J Gen Intern Med. 2020 Mar;35(3):855-864. doi: 10.1007/s11606-019-05476-8. Epub 2019 Nov 11.
- 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 38665744Samant P, Tawde P, Tawde DN. Understanding How Patients With Lumbar Radiculopathy Make Sense of and Cope With Their Symptoms. Cureus. 2024 Mar 26;16(3):e56987. doi: 10.7759/cureus.56987. eCollection 2024 Mar.
- Background: PubMed 38440379Pojskic M, Bisson E, Oertel J, Takami T, Zygourakis C, Costa F. Lumbar disc herniation: Epidemiology, clinical and radiologic diagnosis WFNS spine committee recommendations. World Neurosurg X. 2024 Feb 20;22:100279. doi: 10.1016/j.wnsx.2024.100279. eCollection 2024 Apr.
- 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.
Arnab Altaf, PP DPT principal investigator
Riphah International University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF with electrical stimulation and PNF without electrical stimulation 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 27 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain numeric rating scale (time frame: 6th week). The study lists 2 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 NCT06707779, which also lists 6 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 27 Nov 2024.