Lumbar Disc HerniationPNFNCT03651440
Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Endurance in Lumbar Disc Hernia
A study testing PNF, lumbar stabilization training and Physical Therapy in people with Lumbar Disc Herniation, run by Baskent University.
Trial summary
Background/Objective: This study investigates the effect of lumbar stabilization and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance. Read more about this study
- Who is it for?
- Ages 15 to 69 years, women only
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- PNF, lumbar stabilization training and Physical Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 1 Jan 2015
- 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 15 to 69 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who were graded as "protrusion and bulging lumbar herniation" according to the Macnab Classification.
Who cannot join
- Subjects with acute radicular signs or symptoms and those who had radiographic evidence of inflammatory disease affecting the spine, tumor, fracture, spondylolysis, spondylolisthesis, or scoliosis.
About this study
Official title: Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Muscle Endurance in Patients With Lumbar Disc Hernia
Background/Objective: This study investigates the effect of lumbar stabilization and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance.
Methods: Sixty-four participants between the ages of 15 and 69 years, graded "protrusion and bulging lumbar herniation" according to the Macnab Classification, were divided into four groups of 16: lumbar stabilization training (strength training, 5 days/week for 4 weeks); PNF training (5 days/week for 4 weeks); physical therapy (hot pack, TENS, ultrasound, 5 days/week for 4 weeks); and control (without any application). Sociodemographic features were recorded and muscle strength tested. Before and after exercise, a visual analog scale (VAS) and Oswestry Disability Index (ODI) were measured by a physical therapist. After 4 weeks, the evaluations were repeated.
Read more
Results: There were significant increases in muscle strength and muscle endurance in the lumbar stabilization group, who also showed significant improvement in pain intensity at rest and during activity, and in ODI (p<0.05). Similar results were observed in the PNF group (p<0.05), although not to the same extent. Patients undergoing physical therapy showed significant differences only in pain intensity at rest, at activity, and in ODI (p<0.05).
Conclusion: Undertaking an appropriate physiotherapy and rehabilitation program aiming to reduce waist circumference of patients with low muscle strength and low muscle endurance will help to increase muscle strength and endurance and reduce pain, and contribute toward the correction of functional disabilities.
Read the detailed description
Lumbar disc herniation (LDH) is a clinical entity characterized by compression of the spinal nerve roots and resultant back and leg pain. Though uncommon, LDH has been reported as a cause of recurrent low back pain.
Although more than 100 risk factors have been identified for LDH, it is difficult to determine a specific etiology. The most important risk factors are intense sporting activity, heavy lifting, frequent rotation of the body, exposure to vibrations, age, tall stature, obesity, smoking, and psychological and genetic factors.
It has been shown that in LDH patients; the strength and endurance of the back and abdominal muscles are reduced, and this aspect has been reported as a major predisposing factor for low back pain. Hence, an exercise program as part of conservative treatment of low back pain and after surgery would be of potential benefit for patients. Twomey and Taylor have shown that behavioral and cognitive principles combined with exercise programs can be effective in reducing disability in patients with chronic low back pain.
The severity of symptoms in disc herniation depends not only on the amount of herniated disc pressure but also on nervous irritability. To reduce the sensitivity of nerve fibers to pain, symptomatic initiatives that include drugs, physical therapy, and psychological methods can be successful. The primary purpose of physical therapy is control of pain and inflammation, and secondarily to improve symptoms such as stiffness in the joints and muscle spasms. Physical therapy also delivers psychological effects. Agents used in physical therapy are generally administered in a combined regimen. We undertook this study to investigate the effect of lumbar stabilization training and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance.
Results The groups showed no difference in demographic and clinical characteristics( p>0.05).
When groups' evaluations before and after treatment were compared, statistically significant differences were found in VAS after treatment (at rest), VAS (at activity), Oswestry Disability Index (ODI), abdominal strength, endurance of back extensor, left hip flexion flexibility, sit and reach flexibility, 60°/sec trunk flexion, 90°/sec trunk extension, 90°/sec trunk flexion, 120°/sec trunk flexion, and 120°/sec trunk extension.
When pairwise comparisons of groups were conducted, there were significant differences in the stabilization group's ODI, left hip flexion flexibility, sit and reach flexibility, 90°/sec trunk extension, and 90°/sec trunk flexion muscle strength values when compared with values in the PNF group.
- Conditions
- Lumbar Disc Herniation
- Being tested
- PNF, lumbar stabilization training, Physical Therapy, Control
- Keywords
- Disc herniation, Endurance, Lumbar stabilization exercise, PNF, Strength
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFOther
PNF
lumbar stabilization trainingOther
lumbar stabilization training
Physical TherapyOther
Physical Therapy
ControlOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| lumbar stabilization training | Experimental | lumbar stabilization training exercises Receives: Other: lumbar stabilization training |
| PNF training | Experimental | PNF training exercises Receives: Other: PNF |
| physical therapy | Experimental | HP,TENS US Receives: Other: Physical Therapy |
| control | Sham comparator | NO APPLİCATİON Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
. A standard visual analog scale (VAS) was a used to assess pain. The patients graded their low back pain on a 10-point scale, anchored with the descriptors "no pain" at one end and "pain as bad as it could possibly be" at the other. Maximum pain severity was assessed by a blind-testing physician using the standard VAS
Measured: 4 weeks
Secondary outcomes (1)
Oswestry Disability Index
The Oswestry Disability Questionnare was used to assess pain. The maximum score in this questionnaire is 50, which represents 100% disability.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 May 2014
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Baskent University
- Investigators
- mitat koz, Prof.Dr., Study director, Ankara Universitynilay comuk balcı, Assoc. Prof, Principal investigator, Baskent Universitynuri çetin, MD.Prof.Dr., Principal investigator, Baskent Universityatakan yılmaz, Pt, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651440
- Sponsor's protocol ID
- KA14/36
- Acronym
- PNF
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PNF and Lumbar Stabilization Exercises on Muscle Strength and Muscle Endurance in Patients With Lumbar Disc Hernia
- ClinicalTrials.gov ID
- NCT03651440
- Acronym / sponsor ID
- PNF / KA14/36
- Conditions
- Lumbar Disc Herniation
- Keywords
- Disc herniation, Endurance, Lumbar stabilization exercise, PNF, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 29 Aug 2018 (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.
Background/Objective: This study investigates the effect of lumbar stabilization and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance.
Methods: Sixty-four participants between the ages of 15 and 69 years, graded "protrusion and bulging lumbar herniation" according to the Macnab Classification, were divided into four groups of 16: lumbar stabilization training (strength training, 5 days/week for 4 weeks); PNF training (5 days/week for 4 weeks); physical therapy (hot pack, TENS, ultrasound, 5 days/week for 4 weeks); and control (without any application). Sociodemographic features were recorded and muscle strength tested. Before and after exercise, a visual analog scale (VAS) and Oswestry Disability Index (ODI) were measured by a physical therapist. After 4 weeks, the evaluations were repeated.
Results: There were significant increases in muscle strength and muscle endurance in the lumbar stabilization group, who also showed significant improvement in pain intensity at rest and during activity, and in ODI (p<0.05). Similar results were observed in the PNF group (p<0.05), although not to the same extent. Patients undergoing physical therapy showed significant differences only in pain intensity at rest, at activity, and in ODI (p<0.05).
Conclusion: Undertaking an appropriate physiotherapy and rehabilitation program aiming to reduce waist circumference of patients with low muscle strength and low muscle endurance will help to increase muscle strength and endurance and reduce pain, and contribute toward the correction of functional disabilities.
Detailed description
Lumbar disc herniation (LDH) is a clinical entity characterized by compression of the spinal nerve roots and resultant back and leg pain. Though uncommon, LDH has been reported as a cause of recurrent low back pain.
Although more than 100 risk factors have been identified for LDH, it is difficult to determine a specific etiology. The most important risk factors are intense sporting activity, heavy lifting, frequent rotation of the body, exposure to vibrations, age, tall stature, obesity, smoking, and psychological and genetic factors.
It has been shown that in LDH patients; the strength and endurance of the back and abdominal muscles are reduced, and this aspect has been reported as a major predisposing factor for low back pain. Hence, an exercise program as part of conservative treatment of low back pain and after surgery would be of potential benefit for patients. Twomey and Taylor have shown that behavioral and cognitive principles combined with exercise programs can be effective in reducing disability in patients with chronic low back pain.
The severity of symptoms in disc herniation depends not only on the amount of herniated disc pressure but also on nervous irritability. To reduce the sensitivity of nerve fibers to pain, symptomatic initiatives that include drugs, physical therapy, and psychological methods can be successful. The primary purpose of physical therapy is control of pain and inflammation, and secondarily to improve symptoms such as stiffness in the joints and muscle spasms. Physical therapy also delivers psychological effects. Agents used in physical therapy are generally administered in a combined regimen. We undertook this study to investigate the effect of lumbar stabilization training and proprioceptive neuromuscular facilitation (PNF) training on muscle strength and muscle endurance.
Results The groups showed no difference in demographic and clinical characteristics( p>0.05).
When groups' evaluations before and after treatment were compared, statistically significant differences were found in VAS after treatment (at rest), VAS (at activity), Oswestry Disability Index (ODI), abdominal strength, endurance of back extensor, left hip flexion flexibility, sit and reach flexibility, 60°/sec trunk flexion, 90°/sec trunk extension, 90°/sec trunk flexion, 120°/sec trunk flexion, and 120°/sec trunk extension.
When pairwise comparisons of groups were conducted, there were significant differences in the stabilization group's ODI, left hip flexion flexibility, sit and reach flexibility, 90°/sec trunk extension, and 90°/sec trunk flexion muscle strength values when compared with values in the PNF group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lumbar stabilization training | Experimental | Other: lumbar stabilization traininglumbar stabilization training exercises |
| PNF training | Experimental | Other: PNFPNF training exercises |
| physical therapy | Experimental | Other: Physical TherapyHP,TENS US |
| control | Sham comparator | Other: ControlNO APPLİCATİON |
Who may qualify
- Ages
- 15 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who were graded as "protrusion and bulging lumbar herniation" according to the Macnab Classification.
Key exclusion criteria (1 listed)
- Subjects with acute radicular signs or symptoms and those who had radiographic evidence of inflammatory disease affecting the spine, tumor, fracture, spondylolysis, spondylolisthesis, or scoliosis.
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 |
|---|---|---|
| PNFPNF | Other | PNF training |
| lumbar stabilization traininglumbar stabilization training | Other | lumbar stabilization training |
| Physical TherapyPhysical Therapy | Other | physical therapy |
| ControlControl group | Other | control |
Primary outcome
visual analog scale
Time frame: 4 weeks
. A standard visual analog scale (VAS) was a used to assess pain. The patients graded their low back pain on a 10-point scale, anchored with the descriptors "no pain" at one end and "pain as bad as it could possibly be" at the other. Maximum pain severity was assessed by a blind-testing physician using the standard VAS
1 secondary outcome
Oswestry Disability Index
Time frame: 4 weeks
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 29 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
mitat koz, Prof.Dr. study director
Ankara University
nilay comuk balcı, Assoc. Prof principal investigator
Baskent University
nuri çetin, MD.Prof.Dr. principal investigator
Baskent University
Questions about this trial
What is this clinical trial studying?
A study testing PNF, lumbar stabilization training and Physical Therapy in people with Lumbar Disc Herniation, run by Baskent University.
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 1 inclusion and 1 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
visual analog scale (time frame: 4 weeks). 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 29 Aug 2018.