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Low Back PainNCT06295276

Effect of Teletherapy-supported Training on Nursing Students

A study testing teletherapy-guided exercise programme in people with Low Back Pain and Neck Pain, run by Hochschule Osnabruck at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Low Back Pain, Neck Pain
What is being tested?
teletherapy-guided exercise programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteGermany
Study dates
31 Jan 2024to 31 Dec 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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Nursing students between 18 and 60 years of any gender
  • Self-reported chronic neck and back pain in the last six months (more than three months as described by the International Association for the Study of Pain (IASP)).
  • Speak and understand German

Who cannot join

  • Surgery in the last year on the spine, cervical, thoracic, or lumbar spine
  • Currently on sick leave
  • Acute back pain
  • Severe neurological injuries or symptoms
  • Acute trauma to the musculoskeletal system
  • Renal insufficiency, dialysis
Show all 14Show fewer
  • Severe impairment of the ability to grip with the hand, e.g., rheumatoid arthritis.
  • Severe cardiovascular diseases, e.g. heart failure
  • Severe respiratory diseases, e.g., Chronic Obstructive Pulmonary Disease-COPD
  • Nystagmus
  • Falling tendency/balance disorders
  • Latex allergy, as rubber band may be made of latex
  • Lack of ability to stand, inability to stand safely without the help of a person or object.
  • A spine-specific pain therapy drug treatment within the last three months

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Diakonie Pflege Schule

    Osnabrück, Lower Saxony, 49078

Other trials in Germany

About this study

Official title: Does a Teletherapy-guided Exercise Programme Improve Pain Intensity, Disability, and Quality of Life in Nursing Students With Back and Neck Pain Compared to a Control Group?

Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.

The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.

The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale

Read the detailed description

Intervention of interest: As already mentioned, the protocol of interest is an exercise program supported by online sessions (teletherapy). Exercise routines related to the individual areas of the spine as a functional unit were created based on evidence-based conclusions, especially considering muscle chain activity and appropriate loading parameters

The teletherapy exercise program is carried out once a week via ZOOM by a physiotherapist with thirty years of experience in treating patients with musculoskeletal disorders. Participants are also encouraged to carry out this exercise program themselves at home three times a week so that they have four sessions per week for six weeks. The duration of each session is approximately twenty minutes per session. There are six exercises with three sets and about fifteen repetitions within thirty seconds per set. Exercise description with rationale for exercise selection"). Subjects in the treatment group will also receive a video, rhythm and music files and written materials to help them follow the exercise routines at home, as well as a rubber band. Subjects are also asked to keep a diary in which they record their adherence to the home treatment protocol.

At the beginning of the intervention and after the seventh week, the participants are each assessed with the Patient Reported Outcomes (PROMs), namely ODI, NDI and SF36 short and NRS 11-point scales. At the end of the intervention, participants are interviewed using the Global Rating Scale. Below is a brief description of these instruments.

Control group:

Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments such as physical Therapy (PT), osteopathy, chiropractic as well as other therapeutic exercise (TE) therapies to avoid co-interventions during the 6-week study period. However, pain medication taken by study participants for more than 3 months in all groups, such as non-steroidal anti-inflammatory analgesics (NSAIDs), will be permitted and documented (taking a pragmatic approach). Any change in medication will be monitored and recorded by the PT at each visit.

Being tested
teletherapy-guided exercise programme, Waiting list/control intervention/delayed teletherapy intervention
Keywords
teletherapy
Medical subject headings
Low Back Pain, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • teletherapy-guided exercise programmeOther

    Exercise program guided by online sessions. Subjects perform this exercise program three times a week at home, so that they complete four sessions per week for six weeks. The duration of a session is approximately twenty minutes. There are six exercises with three sets and about fifteen repetitions. Subjects in the treatment group also receive an instructional video. The subjects keep a diary in which they record their adherence to the treatment protocol at home.

    At the beginning of the intervention and after the sixth week, participants are assessed with ODI, NDI and SF36-Short and NRS-11 scales. At the end, we use the Global Rating Scale.

  • Waiting list/control intervention/delayed teletherapy interventionOther

    Subjects in the control group will be advised to maintain their daily routine but will be asked to refrain from other treatments to avoid co-interventions during the 6-week study period. However, the use of painkillers such as non-steroidal anti-inflammatory analgesics (NSAIDs) taken by study participants in all groups for more than 3 months is allowed and will be documented (taking a pragmatic approach). Any change in medication will be monitored and documented by the PT at each visit.

Study groups in NCT06295276
Study groupRoleWhat they receive
InterventionExperimentala six-week muscle training program with 5 exercises 3 times a week as video-guided exercises for homework alone and the same exercises once a week guided by Zoom. The program lasts 6 weeks
Receives: Other: teletherapy-guided exercise programme
Waiting list/control intervention/delayed teletherapy interventionOtherAfter the 6 weeks, participants are offered the opportunity to take part in the intervention program (see above)
Receives: Other: Waiting list/control intervention/delayed teletherapy intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neck Disability Index (NDI)

    10 questions with possible answers ranging from "no pain" to "the worst pain you can imagine", questions for pain intensity, personal hygiene, lifting, reading, headaches, concentration, work, driving, sleeping and the last item leisure activities and recreation.

    Rating:

    Mild complaints 0 points, the most severe complaints with a maximum of 5 points. Maximum score 50 points.

    Score is divided by the possible total score. This value is multiplied by 100% to obtain the score. o (Current restriction : 50) X 100% = score in the NDI <=8% mild symptoms. >40 has very severe symptoms

    Measured: Baseline-6 weeks

  2. Oswestry Disability Index (ODI)

    Extent of pain-related functional limitations in people with back pain. 10 questions with six possible answers each: Pain intensity, self-care, lifting, walking, sitting or standing, sleeping, sex life, social life and traveling.

    Answer options range from "no restrictions due to pain" to "greatest perceived restriction of an activity due to pain".

    Evaluation:

    Points achieved ( )/max. points (50) x100 = % Interpretation: 0% = no restriction, 100% = max. restriction.

    Measured: Baseline-6 weeks

  3. NRS Numeric rating scale for pain

    The Numerical Rating Scale for Pain (NRS) is usually between 0 and 10, with 0 being "no pain" and 10 being "the worst pain imaginable" In a numerical rating scale question, respondents are asked to rate their perceived pain on a predetermined numerical scale. The scale is an ordered number scale with a fixed range that represents the extremes of the measured value

    Measured: Baseline- 6 weeks

Secondary outcomes (2)

  1. Short-Form: SF 36-Quality of life

    SF 36-Quality of life he SF-36 questionnaire (Short Form Health 36) is a questionnaire on quality of life.

    For information on the general. 8 different dimensions Vitality - Physical functioning - Physical pain - General health perception - Physical role functioning - Emotional role functioning - Social role functioning - Psychological well-being For the evaluation, all answers are first converted into predefined points with the help of an evaluation key. The average value of all questions of the respective health dimension

    Measured: Baseline- 6 weeks

  2. Global rating scale

    The Global Rating Scale (GRS) is described as a useful measurement tool with the aim of assessing clinical competence at a general level based on specific word dimensions, measuring instrument to determine the effect of the intervention . This scale is used by us in the study to assess the changes experienced by the patient as a result of treatments or other interventions. Our subjects are asked to rate the change they have experienced after treatment for neck pain and low back pain (LBP) pain using a Global Rating Scale (GRS). Therefore, this questionnaire is only used for the final measurement.

    Participants rate their state of health now compared to before the intervention.

    The values range from -7 to 7. It is measured with -7 as "very much worse", 0 as "unchanged" and 7 as the maximum best value "very much better".

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start31 Jan 2024
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2024

Resources

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
Parallel comparative randomized controlled trial
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295276
Sponsor's protocol ID
HSOsnabruck
Status last verified
May 2025
First submitted
28 Feb 2024
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Adorno ML, Brasil-Neto JP. Assessment of the quality of life through the SF-36 questionnaire in patients with chronic nonspecific low back pain. Acta Ortop Bras. 2013 Jul;21(4):202-7. doi: 10.1590/S1413-78522013000400004.

    PubMed 24453669

  • Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.

    PubMed 29731662

  • Bremer A, Andersson Hagiwara M, Tavares W, Paakkonen H, Nystrom P, Andersson H. Translation and further validation of a global rating scale for the assessment of clinical competence in prehospital emergency care. Nurse Educ Pract. 2020 Aug;47:102841. doi: 10.1016/j.nepr.2020.102841. Epub 2020 Jul 16.

    PubMed 32768897

  • Buskard ANL, Jacobs KA, Eltoukhy MM, Strand KL, Villanueva L, Desai PP, Signorile JF. Optimal Approach to Load Progressions during Strength Training in Older Adults. Med Sci Sports Exerc. 2019 Nov;51(11):2224-2233. doi: 10.1249/MSS.0000000000002038.

    PubMed 31107348

  • Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25.

    PubMed 19632904

  • Quentin C, Bagheri R, Ugbolue UC, Coudeyre E, Pelissier C, Descatha A, Menini T, Bouillon-Minois JB, Dutheil F. Effect of Home Exercise Training in Patients with Nonspecific Low-Back Pain: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Aug 10;18(16):8430. doi: 10.3390/ijerph18168430.

    PubMed 34444189

  • Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.

    PubMed 18201937

  • Dal Farra F, Arippa F, Arru M, Cocco M, Porcu E, Tramontano M, Monticone M. Effects of exercise on balance in patients with non-specific low back pain: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2022 Jun;58(3):423-434. doi: 10.23736/S1973-9087.21.07293-2. Epub 2021 Oct 12.

    PubMed 34636528

  • Eckard T, Lopez J, Kaus A, Aden J. Home exercise program compliance of service members in the deployed environment: an observational cohort study. Mil Med. 2015 Feb;180(2):186-91. doi: 10.7205/MILMED-D-14-00306.

    PubMed 25643386

  • Ennis S, McGregor G, Hamborg T, Jones H, Shave R, Singh SJ, Banerjee P. Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients. BMJ Open. 2017 Aug 11;7(8):e016148. doi: 10.1136/bmjopen-2017-016148.

    PubMed 28801415

  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PubMed 11074683

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PubMed 11690728

  • Filho RAA, Oliveira JJG, Zovico PVC, Rica RL, Barbosa WA, Machado AF, Evangelista AL, Costa EC, Bergamin M, Baker JS, Bocalini DS. Effects of music on psychophysiological responses during high intensity interval training using body weight exercises. Physiol Behav. 2022 Oct 15;255:113931. doi: 10.1016/j.physbeh.2022.113931. Epub 2022 Jul 28.

    PubMed 35907471

  • George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.

    PubMed 34719942

  • Gloth MJ, Matesi AM. Physical therapy and exercise in pain management. Clin Geriatr Med. 2001 Aug;17(3):525-35, vii. doi: 10.1016/s0749-0690(05)70084-7.

    PubMed 11459719

Questions about this trial

What is this clinical trial studying?

A study testing teletherapy-guided exercise programme in people with Low Back Pain and Neck Pain, run by Hochschule Osnabruck at 1 site in Germany.

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 3 inclusion and 14 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 13 May 2025. 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 Germany. 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?

Neck Disability Index (NDI) (time frame: Baseline-6 weeks). The study lists 3 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 NCT06295276, which also lists 62 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 13 May 2025.

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