Low Back PainNCT03760887
A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain
A study testing Home exercise program only and Home exercise program and home program of sensory discrimination in people with Low Back Pain, run by St. Ambrose University at 1 site in United States.
Trial summary
To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Home exercise program only and Home exercise program and home program of sensory discrimination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults over the age of 18
- patients presenting at PT with a primary complaint of LBP
- LBP being present for 3 months or more
- fluent in English
- willing to participate in the study
- They also will need someone who can assist with a sensory discrimination HEP.
Who cannot join
- under age 18
- not able to read/understand the English language
- prisoners
- no medical issues precluding physical therapy treatment (red flags)
- if they had undergone spinal surgery
- if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. - Patients presenting with leg pain only
- Patients with neurological deficit only in the lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.
Read the detailed description
In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.
- Conditions
- Low Back Pain
- Being tested
- Home exercise program only, Home exercise program and home program of sensory discrimination
- Keywords
- Low back pain, Sensory, Tactile, Education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exercise program onlyOther
After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
Home exercise program and home program of sensory discriminationOther
After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.
| Study group | Role | What they receive |
|---|---|---|
| No Home Sensory training | Sham comparator | Patients who perform a home exercise program only Receives: Other: Home exercise program only |
| Home sensory training | Experimental | Patients who perform home exercise and home sensory training Receives: Other: Home exercise program and home program of sensory discrimination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Rating
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Measured: Change from baseline to following treatment immediately upon completion of initial session
Low Back Pain Rating
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Measured: Change from end of treatment initial session to 2-4 days
Lumbar Flexion
Active trunk forward flexion measured in cm (finger tips to floor)
Measured: Change from baseline to treatment immediately upon completion of initial session
Lumbar Flexion
Active trunk forward flexion measured in cm (finger tips to floor)
Measured: Change from end of treatment initial session to 2-4 days
Straight Leg Raise
Neurodynamic measurement of leg raise (lower limb tension test)
Measured: Change from baseline to treatment immediately upon completion of initial session
Straight Leg Raise
Neurodynamic measurement of leg raise (lower limb tension test)
Measured: Change from end of treatment initial session to 2-4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Ambrose University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Farrell, St. Ambrose University
- Investigators
- Kevin Farrell, Principal investigator, St. Ambrose University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760887
- Sponsor's protocol ID
- StAmbroseU sensory
- Status last verified
- Nov 2018
- First submitted
- 26 Nov 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03760887
- Acronym / sponsor ID
- StAmbroseU sensory
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Sensory, Tactile, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- St. Ambrose UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 30 Nov 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.
To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.
Detailed description
In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| No Home Sensory training | Sham comparator | Other: Home exercise program onlyPatients who perform a home exercise program only |
| Home sensory training | Experimental | Other: Home exercise program and home program of sensory discriminationPatients who perform home exercise and home sensory training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults over the age of 18
- patients presenting at PT with a primary complaint of LBP
- LBP being present for 3 months or more
- fluent in English
- willing to participate in the study
Key exclusion criteria (7 listed)
- under age 18
- not able to read/understand the English language
- prisoners
- no medical issues precluding physical therapy treatment (red flags)
- if they had undergone spinal surgery
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 |
|---|---|---|
| Home exercise program onlyAfter 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only | Other | No Home Sensory training |
| Home exercise program and home program of sensory discriminationAfter 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day. | Other | Home sensory training |
Primary outcome
Low Back Pain Rating
Time frame: Change from baseline to following treatment immediately upon completion of initial session
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Low Back Pain Rating
Time frame: Change from end of treatment initial session to 2-4 days
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Lumbar Flexion
Time frame: Change from baseline to treatment immediately upon completion of initial session
Active trunk forward flexion measured in cm (finger tips to floor)
Lumbar Flexion
Time frame: Change from end of treatment initial session to 2-4 days
Active trunk forward flexion measured in cm (finger tips to floor)
Straight Leg Raise
Time frame: Change from baseline to treatment immediately upon completion of initial session
Neurodynamic measurement of leg raise (lower limb tension test)
Straight Leg Raise
Time frame: Change from end of treatment initial session to 2-4 days
Neurodynamic measurement of leg raise (lower limb tension test)
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 23 Apr 2019.
- BackgroundLouw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Kevin Farrell principal investigator
St. Ambrose 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 Home exercise program only and Home exercise program and home program of sensory discrimination in people with Low Back Pain, run by St. Ambrose University at 1 site in United States.
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 6 inclusion and 7 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 23 Apr 2019. 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 United States. 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. 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?
Low Back Pain Rating (time frame: Change from baseline to following treatment immediately upon completion of initial session). The study lists 6 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 NCT03760887, which also lists 1 linked publication.
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 23 Apr 2019.