General Low Back Hip and Hamstring FlexibilityEarly Phase 1NCT01066325
Improving Flexibility With a Mindbody Approach
A Early Phase 1 study testing Neuro Emotional Technique and Stretching Instruction in people with General Low Back Hip and Hamstring Flexibility, run by Parker Research Institute at 1 site in United States.
Trial summary
The objectives of this study are to investigate if Neuro Emotional Technique (NET) will impact back and leg flexibility over both the short-term and the long-term. It is hypothesized that NET will improve flexibility and that these changes are durable. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- General Low Back Hip and Hamstring Flexibility
- What is being tested?
- Neuro Emotional Technique and Stretching Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Aug 2010
- Phase
- Early Phase 1
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 45 years.
Who cannot join
- A currently diagnosed physical or mental health problem
- Pain on forward bending
- Pregnancy
- NOTE: For this study, no compensation is possible.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to investigate if Neuro Emotional Technique (NET) will impact back and leg flexibility over both the short-term and the long-term.
It is hypothesized that NET will improve flexibility and that these changes are durable.
Read the detailed description
General flexibility is a key component of health, wellbeing and general physical conditioning. In fact, lack of flexibility has been associated with an increased risk of developing musculoskeletal injuries and underperformance.
It has been previously shown that a regular stretching routine will improve flexibility relatively quickly. However, when the routine is discontinued or when stretching is not performed regularly, flexibility is also quickly lost. Therefore, an alternative intervention with longer retention would be desirable.
The reason for reduced flexibility, or a shortened muscle length, can be multifactorial. Reduced flexibility can be due to physical causes, such as an acute injury or strength training. Likewise, mental factors, such as anxiety and stress, can also significantly contribute to muscle tension, thereby reducing flexibility. It has been previously shown that somatic symptoms of anxiety can be lessened by treating the psychological symptoms of anxiety. It has also been previously shown that Neuro Emotional Technique® (NET), a chiropractic stress-reduction technique, is effective at reducing stress. Therefore, I hypothesize that NET may be effective at improving general flexibility. Therefore, the aim of this study is to investigate if NET can improve flexibility in the short-term, and if so, if these changes are durable in the long term.
Participants of this study will be randomly divided into three arms: (1) Experimental Arm - which will receive two 20-minute sessions of NET, (2) Active Controls - which will receive two 20-minute sessions of stretching instructions, and (3) Inactive Control - which will receive no intervention or instruction, but simply be assessed.
- Being tested
- Neuro Emotional Technique, Stretching Instruction
- Keywords
- Sit-n-Reach Test, Flexibility, Hamstring, Mindbody, Complementary and Alternative Medicine, Neuro Emotional Technique (NET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro Emotional TechniqueBehavioural
NET is considered an alternative stress-reduction technique. Its aim is to remove neurological abnormalities which have a specified physiopathological pattern. The goal of NET is to normalize the aberrant patterns through a physical correction.
During the NET procedure, various psychological components of the anxious state are considered: cognitions, emotions, and behaviours. These various components are explored for a physiological reaction in the participant. Once a physiological reaction is found, the practitioner helps the participant identify the specific emotion. The procedure is concluded when the patient no longer feels distress or discomfort. Following the intervention, patients frequently report feeling subjective relief.
Stretching InstructionOther
This arm is the Active Control Arm and will receive two 20-minute sessions of Stretching Instructions. During these instructions, participants will hold stretches for not longer than 5 seconds, which in not likely to have any therapeutic effect.
| Study group | Role | What they receive |
|---|---|---|
| NET | Experimental | This arm will receive two 20-minutes sessions of NET 1 week apart. NET (Neuro Emotional Technique) is a non-invasive stress reduction technique. Receives: Behavioral: Neuro Emotional Technique |
| Active Controls | Active comparator | This arm will receive two 20-minute sessions of stretching instructions 1 week apart. Receives: Other: Stretching Instruction |
| Inactive Controls | No intervention | This arm will receive no intervention and no instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sit-n-Reach Test Scores (cm)
Measured: weeks 0, 3
Secondary outcomes (1)
Depression, Anxiety and Stress Scales (DASS) score - change
Measured: weeks 0, 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for General Low Back Hip and Hamstring FlexibilityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anne M. Jensen, Parker Research Institute
- Investigators
- Anne M Jensen, DC, MS, MSc, Principal investigator, Parker Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066325
- Sponsor's protocol ID
- Sit-n-Reach Study
- Status last verified
- Jun 2017
- First submitted
- 9 Feb 2010
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Witvrouw E, Danneels L, Asselman P, D'Have T, Cambier D. Muscle flexibility as a risk factor for developing muscle injuries in male professional soccer players. A prospective study. Am J Sports Med. 2003 Jan-Feb;31(1):41-6. doi: 10.1177/03635465030310011801.
PubMed 12531755Wells GD, Elmi M, Thomas S. Physiological correlates of golf performance. J Strength Cond Res. 2009 May;23(3):741-50. doi: 10.1519/JSC.0b013e3181a07970.
PubMed 19387406Jensen AM, Ramasamy A. Treating spider phobia using Neuro Emotional Technique: findings from a pilot study. J Altern Complement Med. 2009 Dec;15(12):1363-74. doi: 10.1089/acm.2008.0595.
PubMed 20001838Baltaci G, Un N, Tunay V, Besler A, Gerceker S. Comparison of three different sit and reach tests for measurement of hamstring flexibility in female university students. Br J Sports Med. 2003 Feb;37(1):59-61. doi: 10.1136/bjsm.37.1.59.
PubMed 12547745Castro-Pinero J, Chillon P, Ortega FB, Montesinos JL, Sjostrom M, Ruiz JR. Criterion-related validity of sit-and-reach and modified sit-and-reach test for estimating hamstring flexibility in children and adolescents aged 6-17 years. Int J Sports Med. 2009 Sep;30(9):658-62. doi: 10.1055/s-0029-1224175. Epub 2009 Jul 7.
PubMed 19585399Chung PK, Yuen CK. Criterion-related validity of sit-and-reach tests in university men in Hong Kong. Percept Mot Skills. 1999 Feb;88(1):304-16. doi: 10.2466/pms.1999.88.1.304.
PubMed 10214658Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagstromer M, Ottevaere C, Nagy E, Konsta O, Rey-Lopez JP, Polito A, Dietrich S, Plada M, Beghin L, Manios Y, Sjostrom M, Castillo MJ; HELENA Study Group. Reliability of health-related physical fitness tests in European adolescents. The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S49-57. doi: 10.1038/ijo.2008.183.
PubMed 19011654Youdas JW, Krause DA, Hollman JH. Validity of hamstring muscle length assessment during the sit-and-reach test using an inclinometer to measure hip joint angle. J Strength Cond Res. 2008 Jan;22(1):303-9. doi: 10.1519/JSC.0b013e31815f5b7d.
PubMed 18296990Crawford JR, Henry JD. The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. Br J Clin Psychol. 2003 Jun;42(Pt 2):111-31. doi: 10.1348/014466503321903544.
PubMed 12828802Khan RS, Marlow C, Head A. Physiological and psychological responses to a 12-week BodyBalance training programme. J Sci Med Sport. 2008 Jun;11(3):299-307. doi: 10.1016/j.jsams.2007.04.005. Epub 2007 Aug 14.
PubMed 17698412Monti DA, Stoner ME, Zivin G, Schlesinger M. Short term correlates of the Neuro Emotional Technique for cancer-related traumatic stress symptoms: a pilot case series. J Cancer Surviv. 2007 Jun;1(2):161-6. doi: 10.1007/s11764-007-0018-x.
PubMed 18648957Monti DA, Sinnott J, Marchese M, Kunkel EJ, Greeson JM. Muscle test comparisons of congruent and incongruent self-referential statements. Percept Mot Skills. 1999 Jun;88(3 Pt 1):1019-28. doi: 10.2466/pms.1999.88.3.1019.
PubMed 10407911Peterson KB. A preliminary inquiry into manual muscle testing response in phobic and control subjects exposed to threatening stimuli. J Manipulative Physiol Ther. 1996 Jun;19(5):310-6.
PubMed 8792320
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Flexibility With a Mindbody Approach
- ClinicalTrials.gov ID
- NCT01066325
- Acronym / sponsor ID
- Sit-n-Reach Study
- Keywords
- Sit-n-Reach Test, Flexibility, Hamstring, Mindbody, Complementary and Alternative Medicine, Neuro Emotional Technique (NET)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- 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 objectives of this study are to investigate if Neuro Emotional Technique (NET) will impact back and leg flexibility over both the short-term and the long-term.
It is hypothesized that NET will improve flexibility and that these changes are durable.
Detailed description
General flexibility is a key component of health, wellbeing and general physical conditioning. In fact, lack of flexibility has been associated with an increased risk of developing musculoskeletal injuries and underperformance.
It has been previously shown that a regular stretching routine will improve flexibility relatively quickly. However, when the routine is discontinued or when stretching is not performed regularly, flexibility is also quickly lost. Therefore, an alternative intervention with longer retention would be desirable.
The reason for reduced flexibility, or a shortened muscle length, can be multifactorial. Reduced flexibility can be due to physical causes, such as an acute injury or strength training. Likewise, mental factors, such as anxiety and stress, can also significantly contribute to muscle tension, thereby reducing flexibility. It has been previously shown that somatic symptoms of anxiety can be lessened by treating the psychological symptoms of anxiety. It has also been previously shown that Neuro Emotional Technique® (NET), a chiropractic stress-reduction technique, is effective at reducing stress. Therefore, I hypothesize that NET may be effective at improving general flexibility. Therefore, the aim of this study is to investigate if NET can improve flexibility in the short-term, and if so, if these changes are durable in the long term.
Participants of this study will be randomly divided into three arms: (1) Experimental Arm - which will receive two 20-minute sessions of NET, (2) Active Controls - which will receive two 20-minute sessions of stretching instructions, and (3) Inactive Control - which will receive no intervention or instruction, but simply be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NET | Experimental | Behavioral: Neuro Emotional TechniqueThis arm will receive two 20-minutes sessions of NET 1 week apart. NET (Neuro Emotional Technique) is a non-invasive stress reduction technique. |
| Active Controls | Active comparator | Other: Stretching InstructionThis arm will receive two 20-minute sessions of stretching instructions 1 week apart. |
| Inactive Controls | No intervention | –This arm will receive no intervention and no instructions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults aged 18 to 45 years.
Key exclusion criteria (4 listed)
- A currently diagnosed physical or mental health problem
- Pain on forward bending
- Pregnancy
- NOTE: For this study, no compensation is possible.
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 |
|---|---|---|
| Neuro Emotional TechniqueNET is considered an alternative stress-reduction technique. Its aim is to remove neurological abnormalities which have a specified physiopathological pattern. The goal of NET is to normalize the aberrant patterns through a physical correction. During the NET procedure, various psychological components of the anxious state are considered: cognitions, emotions, and behaviours. These various components are explored for a physiological reaction in the participant. Once a physiological reaction is found, the practitioner helps the participant identify the specific emotion. The procedure is concluded when the patient no longer feels distress or discomfort. Following the intervention, patients frequently report feeling subjective relief. | Behavioural | NET |
| Stretching InstructionThis arm is the Active Control Arm and will receive two 20-minute sessions of Stretching Instructions. During these instructions, participants will hold stretches for not longer than 5 seconds, which in not likely to have any therapeutic effect. | Other | Active Controls |
Primary outcome
Change in Sit-n-Reach Test Scores (cm)
Time frame: weeks 0, 3
1 secondary outcome
Depression, Anxiety and Stress Scales (DASS) score - change
Time frame: weeks 0, 3
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 20 Jun 2017.
- Background: PubMed 12531755Witvrouw E, Danneels L, Asselman P, D'Have T, Cambier D. Muscle flexibility as a risk factor for developing muscle injuries in male professional soccer players. A prospective study. Am J Sports Med. 2003 Jan-Feb;31(1):41-6. doi: 10.1177/03635465030310011801.
- Background: PubMed 19387406Wells GD, Elmi M, Thomas S. Physiological correlates of golf performance. J Strength Cond Res. 2009 May;23(3):741-50. doi: 10.1519/JSC.0b013e3181a07970.
- Background: PubMed 20001838Jensen AM, Ramasamy A. Treating spider phobia using Neuro Emotional Technique: findings from a pilot study. J Altern Complement Med. 2009 Dec;15(12):1363-74. doi: 10.1089/acm.2008.0595.
- Background: PubMed 12547745Baltaci G, Un N, Tunay V, Besler A, Gerceker S. Comparison of three different sit and reach tests for measurement of hamstring flexibility in female university students. Br J Sports Med. 2003 Feb;37(1):59-61. doi: 10.1136/bjsm.37.1.59.
- Background: PubMed 19585399Castro-Pinero J, Chillon P, Ortega FB, Montesinos JL, Sjostrom M, Ruiz JR. Criterion-related validity of sit-and-reach and modified sit-and-reach test for estimating hamstring flexibility in children and adolescents aged 6-17 years. Int J Sports Med. 2009 Sep;30(9):658-62. doi: 10.1055/s-0029-1224175. Epub 2009 Jul 7.
- Background: PubMed 10214658Chung PK, Yuen CK. Criterion-related validity of sit-and-reach tests in university men in Hong Kong. Percept Mot Skills. 1999 Feb;88(1):304-16. doi: 10.2466/pms.1999.88.1.304.
- Background: PubMed 19011654Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagstromer M, Ottevaere C, Nagy E, Konsta O, Rey-Lopez JP, Polito A, Dietrich S, Plada M, Beghin L, Manios Y, Sjostrom M, Castillo MJ; HELENA Study Group. Reliability of health-related physical fitness tests in European adolescents. The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S49-57. doi: 10.1038/ijo.2008.183.
- Background: PubMed 18296990Youdas JW, Krause DA, Hollman JH. Validity of hamstring muscle length assessment during the sit-and-reach test using an inclinometer to measure hip joint angle. J Strength Cond Res. 2008 Jan;22(1):303-9. doi: 10.1519/JSC.0b013e31815f5b7d.
- Background: PubMed 12828802Crawford JR, Henry JD. The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample. Br J Clin Psychol. 2003 Jun;42(Pt 2):111-31. doi: 10.1348/014466503321903544.
- Background: PubMed 17698412Khan RS, Marlow C, Head A. Physiological and psychological responses to a 12-week BodyBalance training programme. J Sci Med Sport. 2008 Jun;11(3):299-307. doi: 10.1016/j.jsams.2007.04.005. Epub 2007 Aug 14.
- Background: PubMed 18648957Monti DA, Stoner ME, Zivin G, Schlesinger M. Short term correlates of the Neuro Emotional Technique for cancer-related traumatic stress symptoms: a pilot case series. J Cancer Surviv. 2007 Jun;1(2):161-6. doi: 10.1007/s11764-007-0018-x.
- Background: PubMed 10407911Monti DA, Sinnott J, Marchese M, Kunkel EJ, Greeson JM. Muscle test comparisons of congruent and incongruent self-referential statements. Percept Mot Skills. 1999 Jun;88(3 Pt 1):1019-28. doi: 10.2466/pms.1999.88.3.1019.
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.
Anne M Jensen, DC, MS, MSc principal investigator
Parker Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neuro Emotional Technique and Stretching Instruction in people with General Low Back Hip and Hamstring Flexibility, run by Parker Research Institute 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 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: finished, as of the sponsor's last update on 20 Jun 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Sit-n-Reach Test Scores (cm) (time frame: weeks 0, 3). 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 NCT01066325, which also lists 13 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 20 Jun 2017.