Back PainNCT05822947
Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students
A study testing Active manual therapy in people with Back Pain and Back Disorder, run by Cesar A Hincapié, DC PhD at 1 site in Switzerland.
Trial summary
There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Back Disorder, Back Pain, Low
- What is being tested?
- Active manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Nov 2022to 8 Nov 2022
- 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
- 18 years of age or older
- enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.
Who cannot join
- serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
- history of spine surgery
- obvious contraindication to manual therapy (i.e., spinal fracture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students: a Blinding Feasibility Randomized Controlled Trial
There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.
Read the detailed description
Manual therapy remains a guideline-compliant, first-line therapeutic option for back pain. Yet, maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges, particularly concerning: (a) The design of adequate 'sham' controls and (b) the blinding status of participants and outcome assessors. Optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors. Even when conducted in healthy populations and non-clinical settings, blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine, and a research priority for unbiased treatment effect estimation in future trials.
The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants (graduate students enrolled in an epidemiology Ph.D. course) assigned to an active or control intervention immediately after a one-time intervention session. The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors. These two objectives contributed to obtaining valuable preliminary measures of blinding (blinding indices) for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting.
- Conditions
- Back Pain, Back Disorder, Back Pain, Low
- Being tested
- Active manual therapy, Control manual therapy
- Keywords
- Methods, Manual therapy, Randomised trial, Back pain, Feasibility, Blinding assessment
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active manual therapyOther
Soft tissue mobilization of the lumbar paraspinal musculature (3 to 4 minutes).
Control manual therapyOther
Light touch and a breathing exercise (3 to 4 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Active manual therapy | Experimental | Active manual therapy intervention involved mobilization of the lumbar paraspinal musculature. With participants laying prone on a chiropractic table, the intervention provider administered hand-reinforced circumferential movements to six focal areas, using continuous ischemic compression strokes, and adjusting the pressure to participants' tolerability. Receives: Other: Active manual therapy |
| Control manual therapy | Sham comparator | Control MT intervention included light touch to six distal, broad areas of the thoracic region, with a synchronized breathing exercise. Receives: Other: Control manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinding feasibility of participants, measured by the Bang blinding index.
The Bang blinding index ranges from -1 to 1, with 0 representing satisfactory blinding. It can be interpreted as the proportion of participants correctly answering their allocated intervention within an intervention arm beyond chance. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) was deemed compatible with satisfactory blinding, although blinding scenarios (comparing blinding indices in active vs. control arms) were discussed.
Participants were asked: "To which extent do you know which intervention you received?" and were given five possible answers: "I strongly believe I received the active intervention", "I somewhat believe I received the active intervention", "I somewhat believe I received the control intervention", "I strongly believe I received the control intervention", and "I do not know [whether I received the active or control intervention]".
Measured: Immediately after the one-time intervention session (study day 1).
Secondary outcomes (5)
Blinding feasibility of participants, measured by the James blinding index.
The James blinding index ranges from 0 (all correct responses) to 1 (all 'don't know' responses), where 0.5 corresponds to 50% of responses being correct, and 50% incorrect. Lack of satisfactory blinding may be claimed if the two-sided confidence interval of the James blinding index does not cover 0.5.
Immediately after the intervention, participants rated their perception about received intervention on a five-point scale: "I strongly believe I received the active intervention", "I somewhat believe I received the active intervention", "I somewhat believe I received the control intervention", "I strongly believe I received the control intervention", and "I do not know [whether I received the active or control intervention]".
Measured: Immediately after the one-time intervention session (study day 1).
Blinding feasibility of outcome assessors, measured by the Bang blinding index.
The Bang blinding index ranges from -1 to 1, with 0 representing satisfactory blinding. It can be interpreted as the proportion of outcome assessors who correctly answered the allocated intervention of participants within an intervention arm beyond chance.
Outcome assessors were asked, "To which extent do you know which intervention (active intervention or control intervention) the patient received?" on a five-point scale: "I strongly believe that they received the active intervention," "I somewhat believe that they received the active intervention," "I somewhat believe that they received the control intervention," "I strongly believe that they received the control intervention," "I don't know [whether this participant received active or control intervention]."
Measured: Immediately after the one-time intervention session (study day 1).
Factors contributing to perceived intervention arm allocation among study participants.
Factors contributing to perceived intervention arm allocation among study participants were explored with an open-ended free text question: "Please briefly explain your answer regarding the question above [question above: "To which extent do you know which intervention you received?"].
Measured: Immediately after the one-time intervention session (study day 1).
Factors contributing to perceived intervention arm allocation among outcome assessors.
Factors contributing to perceived intervention arm allocation among outcome assessors were explored with an open-ended free text question: "Please briefly explain your answer regarding the question above [question above: "To which extent do you know which intervention (active intervention or control intervention) the patient received?"].
Measured: Immediately after the one-time intervention session (study day 1).
Blinding feasibility of outcome assessors, measured by the James blinding index.
The James blinding index ranges from 0 (all correct responses) to 1 (all 'don't know' responses), where 0.5 corresponds to 50% of responses being correct, and 50% incorrect. Lack of satisfactory blinding may be claimed if the two-sided confidence interval of the James blinding index does not cover 0.5.
Outcome assessors were asked, "To which extent do you know which intervention (active intervention or control intervention) the patient received?" on a five-point scale: "I strongly believe that they received the active intervention," "I somewhat believe that they received the active intervention," "I somewhat believe that they received the control intervention," "I strongly believe that they received the control intervention," "I don't know [whether this participant received active or control intervention]."
Measured: Immediately after the one-time intervention session (study day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start7 Nov 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre, two-parallel group, blinding feasibility randomized controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cesar A Hincapié, DC PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Cesar A Hincapié, DC PhD, Balgrist University Hospital
- Investigators
- Cesar A Hincapié, DC PhD, Principal investigator, Balgrist University Hospital and University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822947
- Sponsor's protocol ID
- SENSATE Blinding
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigator will make supporting information available upon reasonable request without compromising the privacy of the graduate students enrolled in the doctoral-level course.
Publications
Munoz Laguna J, Nyantakyi E, Bhattacharyya U, Blum K, Delucchi M, Klingebiel FK, Labarile M, Roggo A, Weber M, Radtke T, Puhan MA, Hincapie CA. Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students. Chiropr Man Therap. 2024 Jan 29;32(1):3. doi: 10.1186/s12998-023-00524-x.
PubMed 38287417
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students: a Blinding Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05822947
- Acronym / sponsor ID
- SENSATE Blinding
- Conditions
- Back Pain, Back Disorder, Back Pain, Low
- Keywords
- Methods, Manual therapy, Randomised trial, Back pain, Feasibility, Blinding assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cesar A Hincapié, DC PhDUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 21 Apr 2023 (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.
There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.
Detailed description
Manual therapy remains a guideline-compliant, first-line therapeutic option for back pain. Yet, maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges, particularly concerning: (a) The design of adequate 'sham' controls and (b) the blinding status of participants and outcome assessors. Optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors. Even when conducted in healthy populations and non-clinical settings, blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine, and a research priority for unbiased treatment effect estimation in future trials.
The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants (graduate students enrolled in an epidemiology Ph.D. course) assigned to an active or control intervention immediately after a one-time intervention session. The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors. These two objectives contributed to obtaining valuable preliminary measures of blinding (blinding indices) for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single centre, two-parallel group, blinding feasibility randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Active manual therapy | Experimental | Other: Active manual therapyActive manual therapy intervention involved mobilization of the lumbar paraspinal musculature. With participants laying prone on a chiropractic table, the intervention provider administered hand-reinforced circumferential movements to six focal areas, using continuous ischemic compression strokes, and adjusting the pressure to participants' tolerability. |
| Control manual therapy | Sham comparator | Other: Control manual therapyControl MT intervention included light touch to six distal, broad areas of the thoracic region, with a synchronized breathing exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.
Key exclusion criteria (3 listed)
- serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
- history of spine surgery
- obvious contraindication to manual therapy (i.e., spinal fracture)
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 |
|---|---|---|
| Active manual therapySoft tissue mobilization of the lumbar paraspinal musculature (3 to 4 minutes). | Other | Active manual therapy |
| Control manual therapyLight touch and a breathing exercise (3 to 4 minutes). | Other | Control manual therapy |
Primary outcome
Blinding feasibility of participants, measured by the Bang blinding index.
Time frame: Immediately after the one-time intervention session (study day 1).
The Bang blinding index ranges from -1 to 1, with 0 representing satisfactory blinding. It can be interpreted as the proportion of participants correctly answering their allocated intervention within an intervention arm beyond chance. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) was deemed compatible with satisfactory blinding, although blinding scenarios (comparing blinding indices in active vs. control arms) were discussed. Participants were asked: "To which extent do you know which intervention you received?" and were given five possible answers: "I strongly believe I received the active intervention", "I somewhat believe I received the active intervention", "I somewhat believe I received the control intervention", "I strongly believe I received the control intervention", and "I do not know [whether I received the active or control intervention]".
5 secondary outcomes
Blinding feasibility of participants, measured by the James blinding index.
Time frame: Immediately after the one-time intervention session (study day 1).
Blinding feasibility of outcome assessors, measured by the Bang blinding index.
Time frame: Immediately after the one-time intervention session (study day 1).
Factors contributing to perceived intervention arm allocation among study participants.
Time frame: Immediately after the one-time intervention session (study day 1).
Factors contributing to perceived intervention arm allocation among outcome assessors.
Time frame: Immediately after the one-time intervention session (study day 1).
Blinding feasibility of outcome assessors, measured by the James blinding index.
Time frame: Immediately after the one-time intervention session (study day 1).
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 21 Apr 2023.
- Derived from this study: PubMed 38287417Munoz Laguna J, Nyantakyi E, Bhattacharyya U, Blum K, Delucchi M, Klingebiel FK, Labarile M, Roggo A, Weber M, Radtke T, Puhan MA, Hincapie CA. Is blinding in studies of manual soft tissue mobilisation of the back possible? A feasibility randomised controlled trial with Swiss graduate students. Chiropr Man Therap. 2024 Jan 29;32(1):3. doi: 10.1186/s12998-023-00524-x.
- Individual participant dataSharing planned: Yes. The principal investigator will make supporting information available upon reasonable request without compromising the privacy of the graduate students enrolled in the doctoral-level course.
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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.
Cesar A Hincapié, DC PhD principal investigator
Balgrist University Hospital and University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active manual therapy in people with Back Pain and Back Disorder, run by Cesar A Hincapié, DC PhD at 1 site in Switzerland.
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 2 inclusion and 3 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 21 Apr 2023. 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 Switzerland. 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?
Blinding feasibility of participants, measured by the Bang blinding index. (time frame: Immediately after the one-time intervention session (study day 1).). 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 NCT05822947, 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 21 Apr 2023.