Non-Specific Chronic Knee PainNCT04880954
Manual Therapy and Rehabilitation on Pain and Physical Functioning for Chronic Knee Pain
A study testing Soft Tissue Mobilization and Rehabilitation in people with Non-Specific Chronic Knee Pain, run by Neuro Performance Integration at 1 site in United States.
Trial summary
This is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility. Participation will include 2 assessment days and a 12-week treatment cycle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Specific Chronic Knee Pain
- What is being tested?
- Soft Tissue Mobilization and Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 31 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults experiencing non-specific knee pain for 3 or more months. Pain must be 3/10 (VAS) or higher.
Who cannot join
- Pain due to knee surgery, fracture, tumor, trauma, or those on medication for mood disorder (assessed on case by case basis).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neuro Performance Integration
Park City, Utah, 84060
Jake Shores, DC, 435-640-0429, drshores@npipc.com
About this study
Official title: Soft Tissue Mobilization and Rehabilitation on Pain and Physical Functioning for Non-Specific Chronic Knee Pain: A Randomized Clinical Trail
This is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility.
Participation will include 2 assessment days and a 12-week treatment cycle. Assessments will be conducted during week 1 and after treatment. The treatment will vary based on the assigned group. This may include 12 in-person manual therapy sessions occurring once per week and or 12-weeks of at-home therapy occurring 5 times per week.
The greatest risk of participation includes possible muscle/joint soreness, injury during at-home exercises, and loss of confidentiality.
- Conditions
- Non-Specific Chronic Knee Pain
- Being tested
- Soft Tissue Mobilization, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue MobilizationProcedure or surgery
Also called Manual Therapy
Soft Tissue Mobilization will be provided to participants by Licensed Chiropractor focusing on structures of the lower and upper leg. This will be provided for 20 minutes, once per week for 12 weeks.
RehabilitationOther
Also called Injury Prevention Therapy, Isometric Exercise
Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Soft Tissue Mobilization | Experimental | Not described Receives: Procedure: Soft Tissue Mobilization |
| Rehabilitation | Experimental | Not described Receives: Other: Rehabilitation |
| Soft Tissue Mobilization and Rehabiliation | Experimental | Not described Receives: Procedure: Soft Tissue Mobilization; Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Pain
The Visual Analogue Scale (VAS) will be used to quantify pain. The scale ranges from 1 (no pain) to 10 (worst pain).
Measured: This will be measured pre- and post- intervention (week 1 and week 13).
Secondary outcomes (4)
Range of Motion
A goniometer will be used to assess range of motion of the hip and knee.
Measured: This will be measured pre- and post- intervention (week 1 and week 13)
Modified Clinical Test of Sensory Integration and Balance
The Balance Tracking System will be used to assess balance.
Measured: This will be measured pre- and post- intervention (week 1 and week 13).
Isometric Strength
A crane scale will be used to measure changes in isometric strength (pounds). The hamstring and quadricep will be assessed.
Measured: This will be measured pre- and post- intervention (week 1 and week 13).
Limits of Stability
The Balance Tracking System will be used to assess limits of stability.
Measured: This will be measured pre- and post- intervention (week 1 and week 13).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start31 Mar 2021
- Primary completion23 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Specific Chronic Knee 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
- Participants will be randomly assigned to one of three groups 1) Manual Therapy, 2) Rehabilitation, or 3) Combination of both
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuro Performance Integration
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverly Albert, Neuro Performance Integration
- Investigators
- Beverly Albert, MS, Principal investigator, Neuro Performance Integration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880954
- Sponsor's protocol ID
- #21-NPI-101
- Status last verified
- Jul 2021
- First submitted
- 3 May 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Mobilization and Rehabilitation on Pain and Physical Functioning for Non-Specific Chronic Knee Pain: A Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT04880954
- Acronym / sponsor ID
- #21-NPI-101
- Conditions
- Non-Specific Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Neuro Performance IntegrationUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 11 May 2021 (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 is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility.
Participation will include 2 assessment days and a 12-week treatment cycle. Assessments will be conducted during week 1 and after treatment. The treatment will vary based on the assigned group. This may include 12 in-person manual therapy sessions occurring once per week and or 12-weeks of at-home therapy occurring 5 times per week.
The greatest risk of participation includes possible muscle/joint soreness, injury during at-home exercises, and loss of confidentiality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups 1) Manual Therapy, 2) Rehabilitation, or 3) Combination of both
| Arm | Type | Receives |
|---|---|---|
| Soft Tissue Mobilization | Experimental | Procedure: Soft Tissue Mobilization |
| Rehabilitation | Experimental | Other: Rehabilitation |
| Soft Tissue Mobilization and Rehabiliation | Experimental | Procedure: Soft Tissue Mobilization, Other: Rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults experiencing non-specific knee pain for 3 or more months. Pain must be 3/10 (VAS) or higher.
Key exclusion criteria (1 listed)
- Pain due to knee surgery, fracture, tumor, trauma, or those on medication for mood disorder (assessed on case by case basis).
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 |
|---|---|---|
| Soft Tissue MobilizationAlso: Manual TherapySoft Tissue Mobilization will be provided to participants by Licensed Chiropractor focusing on structures of the lower and upper leg. This will be provided for 20 minutes, once per week for 12 weeks. | Procedure or surgery | Soft Tissue Mobilization, Soft Tissue Mobilization and Rehabiliation |
| RehabilitationAlso: Injury Prevention Therapy, Isometric ExerciseParticipants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks. | Other | Rehabilitation, Soft Tissue Mobilization and Rehabiliation |
Primary outcome
Change in Perceived Pain
Time frame: This will be measured pre- and post- intervention (week 1 and week 13).
The Visual Analogue Scale (VAS) will be used to quantify pain. The scale ranges from 1 (no pain) to 10 (worst pain).
4 secondary outcomes
Range of Motion
Time frame: This will be measured pre- and post- intervention (week 1 and week 13)
Modified Clinical Test of Sensory Integration and Balance
Time frame: This will be measured pre- and post- intervention (week 1 and week 13).
Isometric Strength
Time frame: This will be measured pre- and post- intervention (week 1 and week 13).
Limits of Stability
Time frame: This will be measured pre- and post- intervention (week 1 and week 13).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
Beverly Albert, MS principal investigator
Neuro Performance Integration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Mobilization and Rehabilitation in people with Non-Specific Chronic Knee Pain, run by Neuro Performance Integration 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 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. 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. 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 Beverly Albert, MS (435-640-0429, beverlyalbert@npipc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Pain (time frame: This will be measured pre- and post- intervention (week 1 and week 13).). 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 15 Jul 2021.