跳至主要内容
临床试验/NCT06883513
NCT06883513招募中不适用

Osteopathic Manipulative Therapy(OMT) Effects on Post-Acute Sequalae of COVID-19(PASC)

University of Louisville1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)

研究概览

简要总结

This study is investigating the effects of using an Osteopathic Manipulative Therapy (OMT) treatment protocol that was shown to statistically improve smell in individuals suffering from Long-COVID olfactory (smell) dysfunction in a small single-blinded pilot trial conducted during 2021.

The questions this study is trying to answer are:

  1. Does this OMT protocol improve other non-smell related Long-COVID symptoms
  2. Do 2 OMT treatments improve Long-COVID symptoms more than 1 OMT treatment

Participants will:

  1. Week 1: Take an digital survey regarding their Long-COVID symptoms undergo Long-COVID OMT treatment or a placebo treatment
  2. Week 2: Take an digital survey regarding their Long-COVID symptoms then all will undergo Long-COVID OMT treatment
  3. Week 3: Take an digital survey regarding their Long-COVID symptoms
  4. Week 8: Take an digital survey regarding their Long-COVID symptoms

详细描述

II. Description of the protocol and hypothesis with pilot data:

To date, individuals suffering from Long-COVID still do not have a specific proven treatment for this disease as a whole; however, an OMT sequence that was generated for prolonged post-COVID olfactory dysfunction was shown to generate significant increase in smell intensity after one treatment. Below is the abstract for a pilot trial:

Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction In 2019, the emergence of SARS-CoV2 created countless threats to public health that were unique to the pathogen. One of the first cardinal symptoms of infection is a sudden loss of smell and taste. Most people who survive their infection regain their sense of smell; however, a small amount of the population have prolonged decrease, complete absence, or abnormalities of smell long after the infection has resolved. This study represents a single-blinded pilot trial conducted during 2021 to examine the effects of a single treatment with OMT in individuals who have self-identified prolonged post-COVID anosmia, hyposmia or parosmia (n=20). This study was conducted at 2 locations within Ohio University.

Patients were randomly assigned to either the OMT group or a placebo/light touch/sham group by a flip of the coin and subsequently underwent pre-treatment smell testing of 4 items (Orange, Red Onion, Bourbon, and Perfume) they were then treated based on group selection, and subsequently underwent post-treatment smell testing to determine change in olfactory function. It was hypothesized that the OMT group would have a greater improvement in olfactory function when compared to the placebo group. A Mann-Whitney test indicated that the post and pre-treatment differences in the correct smell intensity scores of red onions were significantly higher for participants who received OMT treatment (Mdn = 2.00) compared to participants who received a non-osteopathic treatment (Mdn=1.00), U=20, p=0.019, r=5. There was a correlation of an increase in smell intensity in 2 out of the 3 remaining smell items, the mean difference between pre-smell treatment and post-smell treatment in the OMT group was higher than the placebo group. This therapy is a potential treatment for individuals suffering from this PASC related symptom and should be investigated further to determine the magnitude of OMT's effects on prolonged post-COVID olfactory dysfunction.

Side effects from the treatment group in the above study were minor but included light-headedness, drowsiness. After one treatment, there was significant improvement in olfactory dysfunction in participants in the treatment group as outlined by the study above. A poster presentation for the above study was accepted at 3 national conferences (American Academy of Osteopathy, American Academy of Physical Medicine and Rehabilitation, and American College of Physicians in San Diego) this past year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Individuals must claim they have had a prior positive SARS-CoV-2 test at least 6-weeks before the consenting process to proceed with the study
  • •Individuals must claim they have at least one of the following symptoms greater than 6-weeks post infection that is affecting their daily life(these symptoms correlate with the SBQ™-LC):
  • •Symptoms of Long Covid Inclusion Criteria:
  • •Shortness of breath or Difficulty Breathing
  • •Difficulty with Movement (balance or tremor)
  • •Muscle Pain or stiffness
  • •Changes in sexual desire
  • •Worsening Generalized Pain
  • •Difficulty with Sleep
  • •Changes in Mood (anxiety or depression)
  • •Changes in Erectile function (Biological males only)
  • •Palpations (irregular heart beats)
  • •Altered Taste
  • •Changes in your Hair
  • •Changes in urination
  • •Dizziness
  • •Altered Smell
  • •Changes in Skin
  • •Changes in bowels
  • •Indigestion
  • •Dry or irritated eyes
  • •Changes in sweating
  • •Difficulty with Cognition (memory or thinking)
  • •Stomach Pain
  • •Changes in menstruation (Biological females only)
  • •Chills or shivering

排除标准

  • •If anyone denies they have any of the above symptoms before consent, they will be excluded from the trial
  • •They will also be excluded from the trial if they have suffered any fractured bones in the last 3 months (this will further decrease risk to the patient as the patient will be moved by the physician during the treatment protocol)
  • •Participants who are enrolled in other Long-COVID trials that have an intervention during their participation in this trial will be excluded. However, if they have a history of enrollment in a long-covid trial that has no interventions during this trial, they will not be excluded based on their history of acquiring experimental treatment.

研究组 & 干预措施

OMT treatment

Experimental

Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity

干预措施: Osteopathic Manipulative Therapy Long-COVID protocol (Other)

OMT treatment

Experimental

Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity

干预措施: Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol (Other)

OMT sham

Sham Comparator

Participants will undergo an OMT treatment sequence that is not targeting areas that was targeted by the OMT treatment group. This will still be OMT, just not Long-COVID targeted OMT. Individuals who have had OMT before study will still be receiving treatment so they will be "blinded".

干预措施: Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol (Other)

结局指标

主要结局

The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)

时间窗: On arrival for baseline before any treatment (week 1). On arrival for 2nd treatment (week 2). 7 days after 2nd treatment (week 3). Final Survey on week 8 of post-enrollment

The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) is a validated tool generated to assess for Long-COVID symptom burden generated by the University of Birmingham in the UK. The SBQ™-LC assesses 123 different symptoms of Long COVID. All items use the recall period "In the last 7 days..." and are scored according to one of the following: 1. symptom presence (Yes/No); 2. symptom frequency (0 = Never to 3 = Always); 3. symptom severity (0 = None to 3 = Severe); 4. or Interference in daily life (0 = Not at all to 3 = Severely). The SBQ™-LC has a Flesch-Kincaid Reading Grade level score of 5.33 suggesting it would be understood by a person with a 6th grade reading level according to the American education system. The SBQ™-LC's SMOG Index score of 8.27 means it should be understood by 93% of UK adults.(8-10) Higher scores suggest worsening symptom severity. Maximum raw score depends on which independent scale within the tool is measured. Ranges from 5-38 depending

次要结局

  • Heart Rate (HR)(Each in-person treatment event, total of 1 HR at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 HR readings)
  • Blood Pressure(BP)(Each in-person treatment event, total of 1 BP at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 BP readings)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Stenta

Co-Investigator

University of Louisville

研究点 (1)

Loading locations...

相似试验