Spinal FusionNCT05354830
The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery
A study testing Foot Massage in people with Spinal Fusion and Pain, Postoperative, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion, Pain, Postoperative
- What is being tested?
- Foot Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having TPF surgery,
- Be over 18 years old,
- No nerve damage or psychiatric disease in the history,
- No central nervous system metastasis or disease,
- No irritation or ulceration in the skin area to be massaged,
- No history of deep vein thrombosis
Show all 9Show fewer
- To be able to speak and understand Turkish and to be able to read and write,
- Patients with an ASA score of 1 and 2,
- It is voluntary to participate in the research.
Who cannot join
- Not wanting to leave the study for any reason,
- Patients with an ASA score of 3 and above,
- Complication development.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan 2. Abdülhamid Han Training and Research Hospital
Istanbul, Üsküdar
About this study
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.
Read the detailed description
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most commonly used types of massage today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. It is stated that Ibn-i Sina talked about the benefits of massage and included this subject in the world-famous source of information, El Kanun Fi't Medicine. It is reported that massage therapy started to be applied in the USA in the mid-1800s and continued its development by using it for different purposes, while in England, nine nurses came together and founded the Massage Association in 1894. In Turkey, it is stated that massage was first applied in Gülhane Serriyat Hospital in 1909 by physical therapists for treatment purposes. Spinal stabilization and fusion techniques for various pathological conditions of the spine began in the 1990s and have now become a surgical standard. The main purpose of surgical treatment in spinal disorders; to correct spinal deformity, increase spinal fusion rates, provide neurological decompression, ensure normal stability, and facilitate rehabilitation by reducing pain following surgery. He has defined many surgical intervention methods for the spine, and these are roughly classified as anterior, posterior and lateral intervention methods. Among these methods, posterior intervention methods are used most frequently. Posterior spine stabilization; It is performed using transpedicular screw and posterior bone fusion. Surgical intervention in degenerative disc disease; It can be applied with open and percutaneous fixation techniques. Transpedicular fixation (TPF); It is one of the most effective surgical methods in the treatment of spinal instability in terms of providing anatomical reduction, stable fixation and early mobilization. It immobilizes the mobile segment of the spine by allowing adequate decompression of neural structures and ensuring bone fusion. Screws in transpedicular fixation surgery; It can be implanted at different levels of the spine such as the cervical, thoracic, lumbar and sacral regions. Pain is a part of the common experiences that people live most of the time, and it is a complex sensation that affects people, is affected by individual characteristics, is always subjective, subjective, and difficult to understand and define. Pain affects the life of the individual physically, mentally and socially and reduces the quality of life of individuals. Therefore, controlling the pain experienced by individuals is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Today, pharmacological methods are widely used in the control of pain. However, when analgesics are used unconsciously and intensively, they have a negative effect on some physiological functions; Especially in cases where narcotics are used, undesirable situations such as tolerance development due to increasing the dose are encountered each time. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought that it reduces edema by accelerating circulation, muscle tension and anxiety when stimuli reach the spinal cord, and pain sensation by stimulating peripheral sensory receptors. As with every surgical procedure, intense postoperative pain occurs especially after spinal surgery. Many factors play a role in the emergence of this pain. One of these is the postoperative inflammatory tissue response. Another factor is the long-term use of automatic retractor systems placed on the paravertebral muscles during spinal surgery. Undesirable severe low back pain in the postoperative period due to prolonged paravertebral muscle retraction is a common and distressing condition for both the patient and the surgeon in the early postoperative period. Therefore, intensive and strong analgesic treatments and even narcotic analgesics have to be used in the early postoperative period. It is stated that pain increases the level of depression, this situation lowers the pain threshold and negatively affects sleep quality in pain and depression. Sleep disorders reduce the quality of life; It increases the risk of falling, the cost of treatment, and most importantly, the death rate in patients. Foot massage provides the transfer of sensory stimuli to the brain by stimulating the nervous system and increasing dopamine secretion. The advantages of foot massage are that it is easy to apply, inexpensive, and no special equipment is needed. Studies on pain and anxiety management with foot massage; shows that it is possible to reduce the pain of patients with this method.
- Conditions
- Spinal Fusion, Pain, Postoperative
- Being tested
- Foot Massage
- Keywords
- Foot massage, Sleep quality, Spinal surgery, Postoperative pain
- Medical subject headings
- Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot MassageOther
Foot Massage
| Study group | Role | What they receive |
|---|---|---|
| Foot Massage | Experimental | Patients undergoing TPF surgery and foot massage Receives: Other: Foot Massage |
| Control | No intervention | Those who underwent TPF surgery and did not receive foot massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Visual Analogue Scale
The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Measured: 12 months
Sleep Richard-Campbell Sleep Questionnaire
A score of "0-25" from the scale indicates that the scale is very bad, and a score of "76-100" indicates that the scale is very good.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 May 2022
- Primary completion1 Jun 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Eda Polat, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354830
- Sponsor's protocol ID
- IstanbulMU15
- Status last verified
- Nov 2023
- First submitted
- 17 Apr 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The work will not be shared after publication.
Publications
Abbaspoor Z, Akbari M, Najar S. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial. Pain Manag Nurs. 2014 Mar;15(1):132-6. doi: 10.1016/j.pmn.2012.07.008. Epub 2013 Jan 24.
PubMed 23352729Ali ZS, Ma TS, Ozturk AK, Malhotra NR, Schuster JM, Marcotte PJ, Grady MS, Welch WC. Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol. Clin Neurol Neurosurg. 2018 Jan;164:142-153. doi: 10.1016/j.clineuro.2017.12.003. Epub 2017 Dec 8.
PubMed 29232645Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.
PubMed 24439644Cuschieri RJ, Morran CG, Howie JC, McArdle CS. Postoperative pain and pulmonary complications: comparison of three analgesic regimens. Br J Surg. 1985 Jun;72(6):495-8. doi: 10.1002/bjs.1800720631.
PubMed 4016522Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
PubMed 20371784Emslie MJ, Campbell MK, Walker KA. Changes in public awareness of, attitudes to, and use of complementary therapy in North East Scotland: surveys in 1993 and 1999. Complement Ther Med. 2002 Sep;10(3):148-53. doi: 10.1016/s0965229902000663.
PubMed 12568143Grealish L, Lomasney A, Whiteman B. Foot massage. A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nurs. 2000 Jun;23(3):237-43. doi: 10.1097/00002820-200006000-00012.
PubMed 10851775Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.
PubMed 23643716Lu WA, Chen GY, Kuo CD. Foot reflexology can increase vagal modulation, decrease sympathetic modulation, and lower blood pressure in healthy subjects and patients with coronary artery disease. Altern Ther Health Med. 2011 Jul-Aug;17(4):8-14.
PubMed 22314629Mahdavipour F, Rahemi Z, Sadat Z, Ajorpaz NM. The effects of foot reflexology on depression during menopause: A randomized controlled clinical trial. Complement Ther Med. 2019 Dec;47:102195. doi: 10.1016/j.ctim.2019.102195. Epub 2019 Sep 14.
PubMed 31780002
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT05354830
- Acronym / sponsor ID
- IstanbulMU15
- Conditions
- Spinal Fusion, Pain, Postoperative
- Keywords
- Foot massage, Sleep quality, Spinal surgery, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 29 Apr 2022 (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.
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.
Detailed description
In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most commonly used types of massage today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. It is stated that Ibn-i Sina talked about the benefits of massage and included this subject in the world-famous source of information, El Kanun Fi't Medicine. It is reported that massage therapy started to be applied in the USA in the mid-1800s and continued its development by using it for different purposes, while in England, nine nurses came together and founded the Massage Association in 1894. In Turkey, it is stated that massage was first applied in Gülhane Serriyat Hospital in 1909 by physical therapists for treatment purposes. Spinal stabilization and fusion techniques for various pathological conditions of the spine began in the 1990s and have now become a surgical standard. The main purpose of surgical treatment in spinal disorders; to correct spinal deformity, increase spinal fusion rates, provide neurological decompression, ensure normal stability, and facilitate rehabilitation by reducing pain following surgery. He has defined many surgical intervention methods for the spine, and these are roughly classified as anterior, posterior and lateral intervention methods. Among these methods, posterior intervention methods are used most frequently. Posterior spine stabilization; It is performed using transpedicular screw and posterior bone fusion. Surgical intervention in degenerative disc disease; It can be applied with open and percutaneous fixation techniques. Transpedicular fixation (TPF); It is one of the most effective surgical methods in the treatment of spinal instability in terms of providing anatomical reduction, stable fixation and early mobilization. It immobilizes the mobile segment of the spine by allowing adequate decompression of neural structures and ensuring bone fusion. Screws in transpedicular fixation surgery; It can be implanted at different levels of the spine such as the cervical, thoracic, lumbar and sacral regions. Pain is a part of the common experiences that people live most of the time, and it is a complex sensation that affects people, is affected by individual characteristics, is always subjective, subjective, and difficult to understand and define. Pain affects the life of the individual physically, mentally and socially and reduces the quality of life of individuals. Therefore, controlling the pain experienced by individuals is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Today, pharmacological methods are widely used in the control of pain. However, when analgesics are used unconsciously and intensively, they have a negative effect on some physiological functions; Especially in cases where narcotics are used, undesirable situations such as tolerance development due to increasing the dose are encountered each time. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought that it reduces edema by accelerating circulation, muscle tension and anxiety when stimuli reach the spinal cord, and pain sensation by stimulating peripheral sensory receptors. As with every surgical procedure, intense postoperative pain occurs especially after spinal surgery. Many factors play a role in the emergence of this pain. One of these is the postoperative inflammatory tissue response. Another factor is the long-term use of automatic retractor systems placed on the paravertebral muscles during spinal surgery. Undesirable severe low back pain in the postoperative period due to prolonged paravertebral muscle retraction is a common and distressing condition for both the patient and the surgeon in the early postoperative period. Therefore, intensive and strong analgesic treatments and even narcotic analgesics have to be used in the early postoperative period. It is stated that pain increases the level of depression, this situation lowers the pain threshold and negatively affects sleep quality in pain and depression. Sleep disorders reduce the quality of life; It increases the risk of falling, the cost of treatment, and most importantly, the death rate in patients. Foot massage provides the transfer of sensory stimuli to the brain by stimulating the nervous system and increasing dopamine secretion. The advantages of foot massage are that it is easy to apply, inexpensive, and no special equipment is needed. Studies on pain and anxiety management with foot massage; shows that it is possible to reduce the pain of patients with this method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled parallel groups
| Arm | Type | Receives |
|---|---|---|
| Foot Massage | Experimental | Other: Foot MassagePatients undergoing TPF surgery and foot massage |
| Control | No intervention | –Those who underwent TPF surgery and did not receive foot massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Having TPF surgery,
- Be over 18 years old,
- No nerve damage or psychiatric disease in the history,
- No central nervous system metastasis or disease,
- No irritation or ulceration in the skin area to be massaged,
Key exclusion criteria (3 listed)
- Not wanting to leave the study for any reason,
- Patients with an ASA score of 3 and above,
- Complication development.
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 |
|---|---|---|
| Foot MassageFoot Massage | Other | Foot Massage |
Primary outcome
Pain Visual Analogue Scale
Time frame: 12 months
The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad. Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Sleep Richard-Campbell Sleep Questionnaire
Time frame: 12 months
A score of "0-25" from the scale indicates that the scale is very bad, and a score of "76-100" indicates that the scale is very good.
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 13 Nov 2023.
- Background: PubMed 23352729Abbaspoor Z, Akbari M, Najar S. Effect of foot and hand massage in post-cesarean section pain control: a randomized control trial. Pain Manag Nurs. 2014 Mar;15(1):132-6. doi: 10.1016/j.pmn.2012.07.008. Epub 2013 Jan 24.
- Background: PubMed 29232645Ali ZS, Ma TS, Ozturk AK, Malhotra NR, Schuster JM, Marcotte PJ, Grady MS, Welch WC. Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol. Clin Neurol Neurosurg. 2018 Jan;164:142-153. doi: 10.1016/j.clineuro.2017.12.003. Epub 2017 Dec 8.
- Background: PubMed 24439644Bagheri-Nesami M, Shorofi SA, Zargar N, Sohrabi M, Gholipour-Baradari A, Khalilian A. The effects of foot reflexology massage on anxiety in patients following coronary artery bypass graft surgery: a randomized controlled trial. Complement Ther Clin Pract. 2014 Feb;20(1):42-7. doi: 10.1016/j.ctcp.2013.10.006. Epub 2013 Oct 25.
- Background: PubMed 4016522Cuschieri RJ, Morran CG, Howie JC, McArdle CS. Postoperative pain and pulmonary complications: comparison of three analgesic regimens. Br J Surg. 1985 Jun;72(6):495-8. doi: 10.1002/bjs.1800720631.
- Background: PubMed 20371784Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338.
- Background: PubMed 12568143Emslie MJ, Campbell MK, Walker KA. Changes in public awareness of, attitudes to, and use of complementary therapy in North East Scotland: surveys in 1993 and 1999. Complement Ther Med. 2002 Sep;10(3):148-53. doi: 10.1016/s0965229902000663.
- Background: PubMed 10851775Grealish L, Lomasney A, Whiteman B. Foot massage. A nursing intervention to modify the distressing symptoms of pain and nausea in patients hospitalized with cancer. Cancer Nurs. 2000 Jun;23(3):237-43. doi: 10.1097/00002820-200006000-00012.
- Background: PubMed 23643716Eadie J, van de Water AT, Lonsdale C, Tully MA, van Mechelen W, Boreham CA, Daly L, McDonough SM, Hurley DA. Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial. Arch Phys Med Rehabil. 2013 Nov;94(11):2083-92. doi: 10.1016/j.apmr.2013.04.017. Epub 2013 May 2.
- Background: PubMed 22314629Lu WA, Chen GY, Kuo CD. Foot reflexology can increase vagal modulation, decrease sympathetic modulation, and lower blood pressure in healthy subjects and patients with coronary artery disease. Altern Ther Health Med. 2011 Jul-Aug;17(4):8-14.
- Background: PubMed 31780002Mahdavipour F, Rahemi Z, Sadat Z, Ajorpaz NM. The effects of foot reflexology on depression during menopause: A randomized controlled clinical trial. Complement Ther Med. 2019 Dec;47:102195. doi: 10.1016/j.ctim.2019.102195. Epub 2019 Sep 14.
- Individual participant dataSharing planned: No. The work will not be shared after publication.
Related trials for Spinal Fusion
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Fusion of Spine, Sacroiliac; Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Massage in people with Spinal Fusion and Pain, Postoperative, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 9 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 13 Nov 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 Turkey (Türkiye). 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?
Pain Visual Analogue Scale (time frame: 12 months). The study lists 2 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 NCT05354830, which also lists 10 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 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.